November 5, 2009 (Boston, Massachusetts) — Supplementing pegylated interferon-alfa2b and ribavirin with a daily dose of vitamin D might increase virologic response rates, according to results of a late-breaking abstract reported here at The Liver Meeting 2009, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
"Vitamin D is a potent immunomodulator whose impact on virologic response rates of interferon-based treatment of chronic HCV [hepatitis C] is unknown," lead investigator Saif M. Abu-Mouch, MD, from the Department of Hepatology, Hillel Yaffe Medical Center, in Hadera, Israel, and colleagues note in their abstract.
"This preliminary study confirms the benefit of adding vitamin D to conventional antiviral therapy in patients with chronic HCV," Dr. Abu-Mouch told meeting attendees.
In the study, 58 patients with confirmed chronic HCV (genotype 1) were randomly assigned to peginterferon-alfa2b (1.5 µg/kg once weekly) plus ribavirin (1000 to 2000 mg/day). Thirty-one patients also received vitamin D (1000 to 4000 IU/day; serum level >32 ng/mL).
The vitamin D group had a higher mean body mass index (27 vs 24 kg/m2; P < .01), viral load (68% vs 58%; P F2, 55% vs 18%; P < .001) than the group that did not receive vitamin D. Demographics, disease characteristics, ethnicity, baseline biochemical parameters, and adherence to treatment were similar in the 2 study groups.
A rapid virologic response was seen at week 4 in 44% of the vitamin D group and in 18% of the control group. At week 12, Dr. Abu-Mouch told Medscape Gastroenterology, 96% of the vitamin D group (26 of 27 patients) were HCV RNA-negative, as assessed by reverse-transcriptase polymerase chain reaction, as was 48% of the control group (15 of 31 patients), which was a significant difference (P < .001), he said.
The combination of peginterferon and ribavirin, the standard of care for chronic HCV, achieves a sustained virologic response in 40% to 50% of naïve patients with genotype 1, the investigators explain in a meeting abstract. Vitamin D in combination with peginterferon-ribavirin "may have synergistic effects," Dr. Abu-Mouch said.
Meeting attendee Laurent Tsakiris, MD, from the Centre Hospitalier Universitaire de Melun in France, who was not involved in the study, told Medscape Gastroenterology that "the study is surprising and promising because vitamin D is something very easy to use and there is no toxicity."
"It's also interesting," he said, "that the group treated with vitamin D had more severe disease than the control group. I think this can be considered a strong result from a small study.
The study did not receive commercial support. Dr. Abu-Mouch and Dr. Tsakiris have disclosed no relevant financial relationships.
The Liver Meeting 2009: 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD): Abstract LB20. Presented November 2, 2009.
That's interesting. Coincidentally, I took at least 1200 of vitamin D every day through supplements during my TX. My Endocrinologist told me to take 600 calcium plus 400 D twice a day, which I did, and I also took a multi vit that had, I think, 400 D a day. I was UND at week 4 (geno 1b).
The endo told me to take those amounts of calcium and D because of my specific health issues (thyroid and surgical menopause) to avoid bone loss.
It seems that Vitamin D is being talked about immensely by the medical community at this time. Deficiency accounts for a lot of ailments. I took quite a lot during tx and still am. I asked my GP to check my vit d and then my hepa. It was too low to start with.They monitored it all the way through treatment. If you have low vit D, it takes several months to build up the levels in your blood. The other problem is that the 'normal' is not the 'optimal'.
Why was this moved from the hep side? I'm just curious why it was moved over to social since it is about hep - not a joke or a video or something? I'm a bit slow I guess on a Monday morning but don't understand why it was switched?
I surmise that the moderator(s) believed this wasn't:
"about medical issues and research aspects of Hepatitis C such as, questions about being newly diagnosed, questions about current treatments, information and participation in discussions about research studies and clinical trials related to Hepatitis..."
In my opinion they are mistaken but this isn't the first instance of that.
Yeah I'm totally confused about it - when I saw the 'thread moved' email I had no clue it was going to be this one since it directly has to do with the treatment of hepc and if people add more vitamin d in...it's a good thing and good idea that is pretty harmless and beneficial anyway.
I thought maybe it was me and I just wasn't getting it........I'm glad to know it's not! :)
Vitamin D: A Potential Role in Cardiovascular Disease Prevention
"November 25, 2009 (Orlando, Florida) — Inadequate levels of vitamin D are associated with an increase in the risk of cardiovascular disease and death, a new observational study has found. Dr Tami L Bair (Intermountain Medical Center, Murray, UT) reported the findings here at the American Heart Association 2009 Scientific Sessions....."
From Medscape Medical News
Vitamin D May Influence Cognitive Dysfunction and Dementia
December 3, 2009 — Vitamin D has been receiving a lot of attention recently, and now researchers report that inadequate vitamin D levels may be involved in cognitive dysfunction and dementia.
Two papers show in separate populations that low levels of vitamin D are associated with cognitive impairment and cerebrovascular disease, including stroke. A third study of only men finds no such association. The papers will appear in the January issue of Neurology.
"What should we make of these studies?" Joshua Miller, PhD, from the University of California in Sacramento, asked in an accompanying editorial. "First, it is evident that the prevalence of vitamin D deficiency is very high among older adults."
Vitamin D deficiency is very high among older adults.
This in and of itself, he says, could warrant expanded screening for vitamin D deficiency and adding supplements. "Whether vitamin D supplements will maintain cognitive function in older adults remains an open question," he notes.
Dr. Miller does not rule out the possibility of reverse causation. "Cognitively impaired older adults may eat poorly or they may have reduced exposure to sunlight, which could lead to reduced vitamin D status."
Investigators led by Cédric Annweiler, MD, from Angers University Hospital in France, conducted a cross-sectional study exploring these questions. Their paper was released early online September 30. The researchers looked at more than 750 community-dwelling older women. Participants were from the French study known as Epidémiologie de l'Ostéoporose. The women were 75 years or older.
The researchers report that 17% of participants had vitamin D deficiency. This was defined as a serum 25-hydroxyvitamin D level of less than 10 ng/mL. Women with vitamin D deficiency had lower mean Short Portable Mental State Questionnaire scores (P < .001). They also had an odds ratio for cognitive impairment of about 2 after controlling for relevant confounders.
The authors conclude that inadequate vitamin D is associated with cognitive impairment in elderly women and that vitamin D supplements may improve or maintain cognitive function.
Two Studies, Similar Conclusion
The second report, by investigators led by Jennifer Buell, PhD, from Tufts University in Boston, Massachusetts, and released November 25, came to a similar conclusion. The researchers also conducted a cross-sectional study — this one of more than 300 men and women.
Participants were 65 years or older and were involved in the Nutrition and Memory in Elders study. They were evaluated for dementia and cerebrovascular disease and underwent magnetic resonance imaging to assess overall and regional brain volumes, white matter hyperintensity, and infarcts.
Investigators show that 14% of the study sample had inadequate vitamin D. Another 44% were classified as vitamin D insufficient (10 to 20 ng/mL).
Patients with low vitamin D levels had higher white matter hyperintensity volume and a higher prevalence of large vessel infarcts. Low vitamin D level was also linked with an odds ratio of about 2 for all-cause dementia, Alzheimer's disease, and stroke after controlling for relevant confounders.
The authors conclude that vitamin D deficiency is associated with an increased risk for dementia and cerebrovascular disease and that vitamin D may have vasculoprotective properties.
However, a third report, also released November 25, came to a different conclusion.
Third Study Questions Evidence
Investigators led by Yelena Slinin, MD, from the VA Medical Center and the University of Minnesota at Minneapolis, found little evidence linking vitamin D and cognitive impairment.
The researchers conducted a longitudinal assessment of more than 1600 community-dwelling men. Participants were 65 years or older and were involved in the Osteoporotic Fractures in Men Study.
Investigators assessed cognitive function using the modified Mini-Mental State Examination and the Trails B test.
At baseline, the odds ratios for cognitive impairment were between 1.6 and 1.8 in the lowest vitamin D quartile compared with the highest. However, these odds ratios did not reach statistical significance and were lower after controlling for race, ethnicity, and education.
Low vitamin D level was defined differently in this study at less than 20 ng/mL. In the other 2 studies, vitamin D deficiency was considered less than 10 ng/mL.
For incident cognitive impairment, the odds ratio for a significant decline in Mini-Mental State Examination score was 1.5 in the lowest quartile of vitamin D concentration compared with the highest quartile. The trend across the quartiles was significant. Yet again, control for confounding by race, ethnicity, and education slightly lowered the trend — enough to lose statistical significance.
The authors suggest that additional studies should be performed that include women and tests of other cognitive domains.
Editorialist Dr. Miller argues that this study is limited by a lack of women included in the work. He says it was also limited because the lowest quartile of vitamin D status consisted of all subjects with levels under 20 ng/mL. "Perhaps a reevaluation of the data comparing deficient subjects (<10 ng/ mL) to nondeficient subjects would reveal significant associations," he notes.
"What are needed now are placebo-controlled intervention studies to determine if vitamin D supplements will protect against age-related cognitive decline." In the meantime, Dr. Miller says, neurologists, general practitioners, and geriatricians should be aware of the high prevalence of vitamin D deficiency in their patient populations and the possibility that supplementation could be beneficial.
Adequate vitamin D for patients aged 51 to 70 years are defined as 10 µg/day (400 IU). For people older than 70 years, 15 µg/day (600 IU) is suggested or enough to maintain a vitamin D level of about 30 ng/mL or more. These recommendations, he notes, are primarily for maintaining bone health and are evolving.
Dr. Miller suggests, "The appropriate intake amounts to support brain function in older adults remain to be determined."
Dr. Joshua Miller receives research support from the National Institutes of Health, the US Department of Defense, and the American Cancer Society. Dr. Slinin is a full-time employee of the US Department of Veterans Affairs. The other investigators have disclosed no relevant financial relationships.
Neurology. Published online September 30 and November 25, 2009
Very interesting and something (Vit. D) that I am researching lately. Thanks for posting these studies, Mike. I had a lot of bone loss after TX and am trying track down the cause. Could be a multitude of reasons: poor absorption of calcium caused by PI or riba, low conversion of Vit. D caused by liver damage, dramatically decreased female hormone levels caused by interferon. Gynecologist insisted on calcium + vitamin D supplementation even though my calcium levels were high (but in normal range) throughout TX. Recent tests showed Vit. D at 32 (normal range 30-80). At 6 mo. check-up, I had moved to higher than normal levels of calcium because of supplements and they still wanted me to take the calcium. Screeew that. I sure don't want to keep overdosing on calcium until I get kidney stones or worse. I stopped the calcium and switched to 400-800 units vitamin D after researching that it would be almost impossible to overdose on D and knowing that I have fairly low, though normal, levels of D so have some leeway in adding extra through supplementation. Finally got a decent night's sleep from not getting up for the bathroom all night for my body to rid itself of excess calcium. Nice to think that I might get smarter taking it, too : ).
you done exactly the right thing!! vit d without calcium is what is needed
adding vit d to diet particuarly during tx is nothing new, iam currently pre dosing for forthcoming tx
most heppers are difiecient in vit d , not all of course before someone starts saying "well johnny down the road has'nt"
it seems that it is becoming normal in the states to have a vit d check, as your doctor for that in the uk and he will laugh because by in large british Gp are clueless when it comes to hep c, infact so are the hep c doctors but thats another matter
From Medscape at http://www.medscape.com/viewarticle/516238_4
".....Evaluation and Treatment of Vitamin D Deficiency
Measurement of 25(OH)D is the only means to determine whether a patient is vitamin D deficient or sufficient. The measurement of 1,25(OH)2D is not only useless, but can mislead the physician because it is often either normal or even elevated when a patient is vitamin D deficient and has secondary hyperparathyroidism. Most commercial laboratories report that a 25(OH)D less than 10 ng/mL is synonymous with vitamin D deficiency. Most experts recommend that less than 20 ng/mL should be designated as vitamin D deficiency.[28-30] To maintain a healthy level of 25(OH)D, the recommendation is that it should be above 30 ng/mL.
The easiest way to correct vitamin D deficiency is to fill up the empty vitamin D tank by giving the patient an oral dose of 50,000 IU of vitamin D once per week for 8 weeks. To maintain vitamin D sufficiency, the patient should receive either 50,000 IU of vitamin D once or twice per month thereafter. There is an intramuscular form of vitamin D that is usually not very bioavailable and can cause significant discomfort; therefore it is not recommended. However, in Europe, intramuscular injection of 500,000 IU of vitamin D twice per year has appeared to be effective in preventing vitamin D deficiency.
A multivitamin containing 400 IU of vitamin D is inadequate to satisfy the body's requirement. It is estimated that at least 1,000 IU of vitamin D per day is needed to satisfy the body's requirement....."
1,000 huh my Centrum does only have 400. I think I will have to make a trip to the health store this week.....especially for women that is a huge difference and I know mine is like newleafs on the low end of normal....wouldn't take much to go under easily enough.
They sell D3, which is the form of vit. D made in the skin and then converted by the liver into the form that is assayed for vit. D levels. Mike, you just talked me into taking 2 of the 400's to go with my Centrum. I am outside a lot but we all need to take it in the winter, when so little skin is exposed to the sun.
It's odd to me if it's processed in our livers and our livers are healthier now why is it common for our (hepper) levels to be low - you would think they would go up after treatment. But I guess it's common enough because our doctors test for it routinely.
Vitamin D low - cholesterol high.............yikes so confusing to me all of this I'd think we would be in better shape!
I think that vitamin d deficiency is common in people regardless liver or kidney damage. It's been estimated that a high percentage of people are deficient but it depends on the definition of "deficient".
one needs to make sure to have it monitored regularly. Excess vit D is not good either. Living in the northern hemisphere, it is quite difficult to have excess, but nevertheless it should be monitored.
Here is a good read on 'normal' and 'optimal/ideal' levels of vit d.
Could Vitamin-D Deficiency Account for Higher CV Mortality in Blacks?
January 6, 2010 (Rochester, New York) — "Another paper suggesting a link between low levels of vitamin D and cardiovascular mortality has been published . It also suggests that low vitamin-D levels may contribute to the increased cardiovascular mortality seen in the black population...."
Interesting article about black people. My Father is black and he cleared the virus. My Mother is white and she cleared it too.
I am a mixture of German, Ukranian, Romanian, African, Jamaican, Chinese, Vietnamese, Arawaq Indian among others, yet I am white-skinned and you'd never know I was mixed just by looking at me.
I worried about my Dad taking standard treatment because of articles like these:
African Americans Have Lower Response Rate To Standard Therapy For Hepatitis C
These things were very disappointing to read about, so that was another reason for wanting to heal them with a natural, harmless method. My Father got lots of sunshine and ate lots of meat, and he had lots of fresh Vegetables and Fruit everyday to help him get well, same for my Mother.
January 25, 2010 — Soaking in more sunlight and drinking more dairy may help you ward off colon cancer.
Researchers in Europe have found that people with abundant levels of vitamin D -- the so-called sunshine vitamin -- have a much lower risk of colon cancer. The findings add to a growing body of evidence that suggest vitamin D may have the power to help prevent colon cancer and possibly even improve survival in those who have the disease.
The body makes vitamin D after the skin absorbs some of the sun's rays. You can also get vitamin D by consuming certain foods and beverages, such as milk and cereal, which have been fortified with the vitamin, but few foods naturally contain it.
For the current study, researchers looked at the link between blood levels of vitamin D as well as dietary vitamin D and calcium, and who was at risk for colorectal cancer. They based their findings on information from the European Prospective Investigation into Cancer Study (EPIC), a study of more than 520,000 people from 10 Western European countries. The study participants gave blood samples and completed detailed diet and lifestyle questionnaires between 1992 and 1998.
During the follow-up period, 1,248 patients were diagnosed with colorectal cancer. Researchers compared their lifestyle and diet backgrounds to the same number of healthy patients. They discovered that those with the highest blood levels of vitamin D had a nearly 40% decrease in colorectal cancer risk than those with the lowest levels.
However, the best way to boost your vitamin D level may be a matter of debate. As vitamin D's potential health benefits become more widely advertised, more people may advocate supplementation. However, the researchers say it's unclear if supplements are better at increasing blood levels of vitamin D than a balanced diet and moderate exposure to outdoor sunlight. They caution that the long-term effects of taking large doses of vitamin D supplements have not been well studied.
"Our findings suggest that the potential cancer risk benefits of higher vitamin D levels should be balanced with caution for the toxic potential," they write in today's online version of BMJ. "Before any public health recommendations can be made for vitamin D supplementation, new randomized trials are needed to test the hypothesis that increases in [blood levels of vitamin D] are effective in reducing colorectal cancer risk without inducing serious adverse events."
Colorectal cancer is the third most common cancer in men and women in the U.S., according to the American Cancer Society.
Low Vitamin D Worsens Asthma
By John Gever, Senior Editor, MedPage Today
Published: January 28, 2010
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and
"Low levels of vitamin D correlated with poorer lung function, increased airway reactivity, and reduced response to steroid treatment in adult asthmatics, researchers said. "
Wow you are a psychic Michael just one minute ago the woman I work with here started telling me why I need to begin to take Vitamin D every day. I said oh how much are you taking 2,000? She was like how do you know that????? HA cause I Have smart friends - who needs doctors when you have the forum!!!
Then I see this thread bumped up - timing is everything now I can print that article and look REALLYsmart, thanks! ;)
I don't look for this stuff - positive articles on Vitamin D. Often when I look at the medical news for the day I see another article about yet another possible benefit from Vitamin D. So I post it here.
Vitamin D3 Supplements in Winter May Help Protect Against Influenza A
Laurie Barclay, MD
April 2, 2010 — Vitamin D3 supplementation during the winter is linked to lower incidence of influenza A, particularly in specific subgroups of schoolchildren, according to the results of a randomized, double-blind, placebo-controlled trial reported online in the March 10 issue of the American Journal of Clinical Nutrition.
"To our knowledge, no rigorously designed clinical trials have evaluated the relation between vitamin D and physician diagnosed seasonal influenza," write Mitsuyoshi Urashima, MD, PhD, from Jikei University School of Medicine, Minato-ku, in Tokyo, Japan, and colleagues. "We investigated the effect of vitamin D supplements on the incidence of seasonal influenza A in schoolchildren."
Schoolchildren were randomly assigned to receive vitamin D3 supplements (1200 IU/day) or placebo from December 2008 through March 2009. The main endpoint of the study was the incidence of influenza A, diagnosed by influenza antigen testing (rapid influenza diagnostic test [RIDT]) on a nasopharyngeal swab specimen.
In the vitamin D3 group, 18 (10.8%) of 167 children had influenza A, as did 31 (18.6%) of 167 children in the placebo group (relative risk [RR], 0.58; 95% confidence interval [CI], 0.34 - 0.99; P = .04). The association of decreased influenza A incidence with vitamin D supplements was stronger in children who had not been taking other vitamin D supplements (RR, 0.36; 95% CI, 0.17 - 0.79; P = .006) and in those who started nursery school after age 3 years (RR, 0.36; 95% CI, 0.17 - 0.78; P = .005).
Among children with a previous diagnosis of asthma, 2 children in the vitamin D3 group vs 12 children in the placebo group had asthma attacks as a secondary outcome (RR, 0.17; 95% CI, 0.04 - 0.73; P = .006).
"This study suggests that vitamin D3 supplementation during the winter may reduce the incidence of influenza A, especially in specific subgroups of schoolchildren," the study authors write. "....Moreover, asthma attacks were also prevented by vitamin D3 supplementation."
Limitations of this study include small sample size, lack of data on serum 25-hydroxyvitamin D or on urinary calcium data, and lack of information on the presence or development of influenza A antibodies.
"Future studies should include a larger sample size of schoolchildren without comorbidities to determine the optimal dose and duration of vitamin D supplementation by measurement of serum 25-hydroxyvitamin D, serum and urinary calcium, and titers of antibody to influenza levels," the study authors conclude.
Jikei University School of Medicine supported this study. The study authors have disclosed no relevant financial relationships.
Thanks I was eating lunch and forgot to take my morning dose so you reminded me! It's hard to remember both doses but it makes sense that it would work better somehow if I did it that way - really don't know if it makes a difference!
I'm taking 2,000 a day now. Hopefully the blood work will be better this time.
I cannot belive this,im hearing more and more are ingesting some good supps and are into eating healthy..pinch me...i have to be dreaming again,seems like the tone is changing,maybe all my ranting and raving has gotten tru?
The British Medical Journal has published a remarkable paper confirming that low vitamin D levels obtained in the past are a risk factor for developing colon cancer in the future.
But the study contained an even more significant finding -- as Dr. Cannell's site has reported before, vitamin A, even in relatively low amounts, can thwart vitamin D's association with reduced rates of colon cancer.
This is the largest study to date showing vitamin A blocks vitamin D's effect.
Hidden on page eight of the paper was one sentence and a small table, showing that the benefits of vitamin D are almost entirely negated in those with the highest vitamin A (retinol) intake.
And the retinol intake did not have to be that high -- only about 3,000 IU/day. Young autistic children often take 3,500 IU of retinol a day in their powdered multivitamins, which doesn't count any additional vitamin A given in high single doses.
The finding explains some of the anomalies in other papers on vitamin D and cancer -- similar studies sometimes have widely different results. This may be because the effect of vitamin A was not taken into account. In some countries, cod liver oil, which contains vitamin A, is commonly used as a vitamin D supplement, and in others it is used more rarely, causing differences in the results.
I just had a vitamin D test - don't know the results yet. I didn't even see this post last year, my inadequate vitamin D levels be causing "cognitive dysfunction and dementia."
But, seriously, several folks I work with are vitamin D deficient. I have read articles that vitamin D deficiency is worldwide epidemic and it's just amazing how many dieases vit D deficiency is linked with. If you google "vitamin D deficiency" and click on news you will come up with a whole slew of articles.
Good for you! It is very important to get those levels up to optimal levels. Most of us living in the Northern Hemisphere are deficient. Mine was all the way down to 25 before tx. I've been on Vit D ever since. My levels went up to normal and now I am on a maintenance dose. Am waiting for the results of new tests.
When I had my Vit. D checked I was a very sturdy level on my Vit. D. Perhaps because I've lived in Florida my entire life? I no longer sunbathe, but I used to alot. However, I get alot of Vit. D from my food. I eat yogurt, eat sugar-free pudding, eat low cal/carb ice cream and put lactose-free Vit. D enriched milk in my coffee and cereal. I also eat salmon which has Vit. D in it. I eat nuts. And I get Vit. D in my fortified cereal and multi-vit. With that in mind, I don't take alot of added Vit.D on a daily basis since my levels are so good. The Vit. A that is in my multi-vit is 2500 I.U. or 50% of the RDA. Susan400
yes there is a torrent of irrefuteable proof that supplements can improve a wide variety of diseases and conditions, and now we have a study that seems to show a simple unpatentable vitamin can improve SVR in G1 heppers more than the famed telepravir can, and instead of the dreaded itch, you get protection from flu, asthma, cancer, mental decline, and falling if your elderly.
The only reason there is not torrent of similiar trials revealing other safe and effective supplements is the lack of clinical trials due to the fact the compounds are not patentable. Nature knows nothing of the human distincton of patentable/nonpatentable and cares not who makes money. Some molecules work, some don't. Of course where we look (patentable products= good clinical trials) we will find proof. Were we don't look (freely availble non-patentable products) we will not find proof. There is nothing inherant about "supplements" which makes them, as a group, less viable than "drugs". In fact the distinction is entirely artificial- they are all drugs to the virus.
If Vitamin D was patentable, it would be heralded as a fantastic bereakthru in hepatitis treatment, with twice the advantage of telepravir, and a host of other benefits instead of new bothersome side effects.
I would love to wrong, in which case I eagerly await the definitive phase III trials which, based on such dramatic results, are surely being developed by competent medical authorities as we speak to improve present treatment. Even the interferon manufactorers could benefit from this kind of increase in effectiveness in their treatments. I reserve final judgement until the results from these large, randomized, placebo controlled trials definitively prove what role vitamin D has in augmenting current SOC.
If, as I have read on this board many times, there is no bias in government and industry about trials where benefit is clearly shown, or at least very promising, these trials will be organized quickly, and in america-not just Isreal- perhaps with vitamin D arms added to currently planned SOC trials for previous non-resonders/relapsers etc, and, with little to no added risk to current trial patients, we can demonstrate that this original trial was a fluke, or that we can improve SOC clearance times, which sofar has closely predicted SVR, more with vitamin D than with telepravir (as this original trial clearly purports to show) . All we need is bigger, better trials to check weather this translates into SVR or not, and we would be well on our way to clearing our backlog of untreated due to fear of failure.
What are the chances that Vertex is going to let that happen???
If I was on SOC right now I would be adding Vit D to my regiman, and have a private lab ensure my vit D level was >32ng/L. After I carefully check the credentials of the trial organizers, I will begin to consider SOC myself.
Supplemental Vitamin D May Help Reduce Breast Cancer
April 29, 2010 — Vitamin D from supplements may reduce the risk for breast cancer in women with relatively low vitamin D intakes, suggest study findings published online April 14 ahead of print in the American Journal of Clinical Nutrition. The study also found a significant inverse trend for higher calcium intakes but no interaction between vitamin D and calcium. However, no associations were found between overall combined vitamin D or calcium intakes from food and supplements and breast cancer risk.
It is unclear whether the possible association between dietary vitamin D and reduced breast cancer risk is confounded or modified by calcium and vice versa, Laura N. Anderson, from Population Studies and Surveillance, Cancer Care Ontario, in Toronto, Canada, and colleagues note in their article. It is also unclear whether the association between dietary vitamin D and breast cancer differs by menopausal status.
To investigate these uncertainties, the researchers used the Ontario Cancer Registry to identify 3101 women aged 25 to 74 years diagnosed between June 2002 and April 2003 with a first pathologically confirmed breast tumor (case patients). The researchers used random-digit dialing methods to identify 3471 matched women without breast cancer (control subjects). All of the women completed an epidemiologic questionnaire and a modified Block food frequency questionnaire that measured 178 foods and supplements.
Supplemental vitamin D at more than 10 µg/day (400 IU/day) vs no supplemental vitamin D was associated with a reduced risk for breast cancer (adjusted odds ratio [OR], 0.76; 95% confidence interval [CI], 0.59 - 0.98). However, no dose-response relationship was observed.
The study authors note that the mean intake of vitamin D in study subjects was low. Only 13% of case patients and 14% of control subject reported using single-product vitamin D supplements or cod liver oil. No associations were evident between total combined vitamin D intake or vitamin D intake from foods alone and breast cancer risk.
In addition, there were no statistically significant associations between calcium intake from foods, supplements, or total combined intake and breast cancer risk; however, a significant inverse trend was noted across categories of calcium supplement use (P for trend = .04). Calcium supplement use was more common in study participants than was vitamin D supplement use; 33% of case patients and 35% of control subjects took calcium.
Moreover, the results "do not suggest an interaction between calcium and vitamin D intakes, and these 2 variables did not confound each other," according to the researchers. There were also no significant interactions between vitamin D, calcium, or menopausal status, and multivitamin use was not associated with breast cancer risk.
The study authors point out that measuring vitamin D or calcium from foods as opposed to supplements may be more prone to misclassification (potentially biasing results toward the null). It is also possible that foods containing vitamin D and calcium contain other detrimental components that counteract the potential benefits from vitamin D, such as dietary fat in milk. Furthermore, the possibility that the observed associations were the result of chance or residual confounding cannot be ruled out; however, the finding that multivitamin use was not associated with breast cancer risk suggests that the associations are not because of residual confounding by other unmeasured healthy lifestyle traits among supplement users.
Strengths of the study, the authors say, include its large sample size, population-based recruitment of case patients and control subjects, and high response rates.
Limitations of the study include observational design, possible misclassification of measurement of vitamin D or calcium from foods vs supplements, and possible chance results or residual confounding.
"Further research is needed to investigate the effects of higher doses of vitamin D and calcium supplements," the researchers conclude.
The study authors have disclosed no relevant financial relationships
Vitamin D Deficiency Linked to Cognitive Impairment in Older Women
April 29, 2010 (Toronto, Ontario) — Vitamin D deficiency appears to increase the risk for cognitive impairment, a large, population-based study of older women shows.
Presented here at the American Academy of Neurology 62nd Annual Meeting, the cross-sectional study shows older women with serum 25-hydroxyvitamin D (25OHD) levels of less than 10 ng/mL had a 2-fold increased risk of global cognitive impairment compared with their counterparts who were not vitamin D deficient.
"After accounting for all potential confounders, our findings showed an association between vitamin D deficiency and global cognitive impairment. These results are congruent with fundamental research and add to the growing body of evidence in favor of the neurological action of vitamin D," principal investigator, Cédric Annweiler, MD, Angers University Hospital in France, told Medscape Psychiatry.
Dr. Annweiler said he became interested in looking at the potential impact of vitamin D on cognitive function when studying risk factors associated with falling in older women in the Epidemiologie de l'Osteoporose (EPIDOS) study. This large, prospective, observational, multicenter cohort study was designed to evaluate risk factors for hip fracture among more than 7500 healthy, community-dwelling older women.
Typically associated with skeletal disorders, vitamin D deficiency is also associated with neuromuscular disorders in humans and severe coordination disorders in animal research, said Dr. Annweiler.
Specific CNS Effects
A neurosteroid hormone, research shows it has specific effects on the central nervous system (CNS), including regulation of neurotransmission, neuroimmunomodulation, and neuroprotection.
According to Dr. Annweiler, few studies have investigated the association between low serum 25OHD and cognitive impairment. A recent systematic review of the literature conducted by his team produced mixed results (Eur J Neurol. 2009;16:1083-1089).
However, the investigators speculated that these inconclusive findings may be explained by the lack of control for potential confounders.
To determine whether there was an association between vitamin D deficiency and global cognitive impairment, the investigators studied 752 women from the EPIDOS cohort. Participants were 75 years and older and were divided into 2 groups according to serum 25OHD concentration — deficient (<10 ng/mL) or nondeficient (≥10 ng/mL).
Cognitive impairment was determined using the Pfeiffer Short Portable Mental State Questionnaire (SPMSQ), a validated, 10-item, composite questionnaire used to screen for organic brain diseases. Cognitive impairment was defined as an SPMSQ score of less than 8.
Investigators controlled for a variety of potential confounders, including age, body mass index, number of chronic diseases, current hypertension, current depression, use of psychoactive drugs, education level, regular physical activity, and serum intact parathyroid hormone and calcium.
Rampant Problem in the Elderly
The results showed that compared with women who were not vitamin D deficient (n = 623) their vitamin D deficient counterparts had a lower mean SPMSQ score (P < .001) and were also more likely to have an SPMSQ score of less than 8 (P = .006).
Adjusted analysis revealed that vitamin D was significantly associated with cognitive impairment (odds ratio, 2.03; P = .001).
The clinical implications, said Dr. Annweiler, appear clear — clinicians need to assess and treat vitamin D deficiency in their older patients for a variety of health reasons that may include preservation of cognitive function.
Vitamin D deficiency is common in the general population but is rampant among the elderly. According to Dr. Annweiler, it is estimated that 70% to 80% of individuals older than 75 years are vitamin D deficient.
Currently, adequate intakes of vitamin D for 51- to 70-year-olds are 400 IU per day and 600 IU for those older than 70 years to maintain a 25OHD level of 30 ng/mL or more. However, Dr. Annweiler noted that these recommendations are based primarily on preservation of bone health alone.
The reason the elderly are more vulnerable to vitamin D deficiency than younger individuals are several-fold and include decreased exposure to sunlight and inadequate dietary intake. In addition, said Dr. Annweiler, the skin of older people is not as efficient at synthesizing UV-B rays into vitamin D.
"This study provides more evidence to support [vitamin D] supplementation in our elderly patients to normalize serum concentrations and help sustain good health. Although we are not certain yet, it may be that this will also be a viable way to prevent or treat cognitive impairment and possibly turn out to be a new management strategy for dementia," said Dr. Annweiler.
The study was initially published earlier this year in the January 5 issue of Neurology. At that time, in an accompanying editorial, Joshua W. Mill, PhD, UC Davis Medical Center, Sacramento, California, echoed Dr. Annweiler's clinical recommendation (Neurology. 2010;74:13-15).
What are needed now are placebo-controlled intervention studies to determine whether vitamin D supplements will protect against age-related cognitive decline. In the meantime, neurologists and geriatricians should be aware of the high prevalence of vitamin D deficiency in their patient populations and the possibility that supplementation could be beneficial," Dr. Mill writes.
Dr. Annweiler said his team plans to prospectively follow up the cohort and examine the potential relationship between vitamin D status and incident dementia. In addition, his team is exploring the possibility of conducting a clinical trial to look at the impact of supplementation on cognitive outcomes.
The study was funded by the French Ministry of Health. Dr. Annweiler and Dr. Miller have disclosed no relevant financial relationships.
American Academy of Neurology (AAN) 62nd Annual Meeting: Abstract S34.003. Presented April 14, 2010.
CMSC-ACTRIMS: Content of OTC Vitamin D Low, Unpredictable
This report is part of a 12-month Clinical Context series.
By Richard Robinson, Contributing Writer, MedPage Today
Published: June 07, 2010
SAN ANTONIO -- Multiple sclerosis (MS) patients taking over-the-counter vitamin D aren't getting what they're paying for, or what their neurologists recommend, according to a study presented here.
The mean vitamin D content from 10 OTC brands was only 33% of what the label claimed, with the actual content ranging from less than 1% to 82% of the advertised level. The study was presented at the meeting of the Joint Consortium of Multiple Sclerosis Centers and America's Committee on Treatment and Research in Multiple Sclerosis.
Vitamin D supplements are increasingly being recommended to MS patients, both for osteoporosis, which is common in the disease, and for presumed immunomodulatory actions as well, according to senior author Peter Calabresi, MD, of the Department of Neurology at Johns Hopkins University in Baltimore. "As the role of vitamin D in immune regulation in MS gains increasing focus, oral supplementation is growing," he said.
The level of recommended supplementation depends on the patient's individual deficiency, although 4000 IU daily is a common dose.
However, given the wide variety of vitamin D3 (cholecalciferol) supplements available and "limited regulation within the nutritional supplement industry, the true vitamin D3 content of over-the-counter supplements is a concern," Calabresi said.
To test levels in commonly purchased supplements, his group collected 10 bottles of OTC supplements from local and on-line retail pharmacies. Vitamin D3 was extracted by standard techniques and samples were analyzed by liquid chromatography and mass spectrometry.
The labeled doses ranged from 400 IU to 10,000 IU, but the mean actual dose was only 33.5% of the labeled dose, with a range from 0.24% to 81.7%.
Lower-dose products tended to be closer to their labeled dose than higher-dose products, with the three 400-IU products averaging 51.5%, the two 1000-IU products averaging 34%, and the three 10,000-IU products averaging 29.9%.
On the other hand, the single worst sample -- the one with only 0.24% of what it claimed -- was a 400-IU sample.
Neither national in-store retail brands nor online brands were more true to their labels.
The discrepancy between the advertised and actual vitamin D content "may contribute to the difficulty for some patients to reach adequate serum vitamin D levels despite supplementation," Calabresi said.
"This reflects the need for increased regulation of the vitamin industry." Because their lab is not certified to do drug testing, Calabresi declined to name the products tested in this study. Patients taking vitamin D supplements should have serum measurements made after starting therapy to determine whether they are reaching target levels, he said.
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