Tuesday, 21 October 2014

Vitamin D trial

Bhargava P, Cassard S, Steele SU, Azevedo C, Pelletier D, Sugar EA, Waubant E, Mowry EM. The Vitamin D to Ameliorate Multiple Sclerosis (VIDAMS) trial: study design for a multicenter, randomized, double-blind controlled trial of vitamin D in multiple sclerosis.Contemp Clin Trials. 2014 Oct. pii: S1551-7144(14)00150-5.

BACKGROUND:Lower levels of vitamin D are associated with increased MS risk and with greater clinical and brain MRI activity in established relapsing MS.
OBJECTIVE:The VIDAMS trial (NCT01490502) evaluates whether high-dose vitamin D supplementation reduces the risk of MS activity.
DESIGN/METHODS:Eligibility criteria include diagnosis of RRMS, age 18 to 50years, and Expanded Disability Status Scale≤4.0. Disease duration and activity requirements depend on whether 2005 or 2010 criteria are used for diagnosis. Enrollment is restricted based on prior MS therapy exposure and recent vitamin D use. After completing a one-month run-in of glatiramer acetate, 172 patients will be randomized 1:1 to oral vitamin D3  5,000IU versus 600IU daily. Clinical visits occur every 12weeks for 96weeks.
RESULTS: Sixteen sites throughout the United States are participating in the trial. Complete enrollment is expected by late 2014, with follow-up through 2016. No interim analyses are planned. The primary outcome for the trial is the proportion of patients experiencing a relapse in each group. Other clinical, patient-reported, and MRI outcomes will be evaluated.
CONCLUSIONS: The VIDAMS trial will provide critical information about the safety and efficacy of vitamin D therapy in RRMS, with implications for MS patients worldwide
So paper for old rope. You write up the trial before you get any data......Mint. 

So we have mega dose verses supermarket multi-vitamin dose. Wonder what ProfG makes of this? This is a multi centre trial with 15 sites in USA taking Vitamin D and copaxone. I wonder how natural sunlight exposure will influence this I guess people in North with get low and high dose and people in south will get low and high doses I guess it adds "noise" into the system. 

18 comments:

  1. Hi MD, do you think you can make this clearer ."D 35,000IU", it's D3 at 5000 IU, not 35,000 IU.
    Thanks

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  2. Prof Mouse,
    It is oral vitamin D3 5,000IU daily, not oral vitamin D 35,000IU daily. So it is the same dose Prof G recommends.

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  3. That is a mega dose and I would need to know the results of this trial before taking 35,000IU daily for 12 weeks. Perhaps 35,000 IU weekly I might consider.
    The natural sunlight like you mention Mouse Doctor and if the patient wears a hat, long sleves, make up such as foundation with sunblock in the sun. Diet and if the MSer eats farmed or wild salmon, trout, sardines and how many times a week. Mushrooms, one study showed that if certain mushrooms when pciked are exposed to sunlight for six to eight hours (with gills facing up) the vitamin D content rises dramatically.

    http://www.dl.begellhouse.com/journals/708ae68d64b17c52,2cbf07a603004731,178ea16f2504f047.html

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    Replies
    1. I've put in an extra space so the confusion as to the dose of vitamin D3 is cleared up. It's 5,000 units of vitamin D3 daily versus 600 units.

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    2. I also read that common button mushrooms or any mushrooms if placed outside in the sunlight for sixty mins the vitamin D content rises quite a bit. I guess gills facing up.
      The study mentioned above with link about certain mushrooms the abstract mentions: Six to eight hours of sunlight exposure stimulated the production of vitamin D (in these mushrooms) from low levels of 134, 66, and 469 IU, respectively, to 46,000, 2760, and 31,900 IU vitamin D, respectively. Tne most vitamin D was produced in Lentinus edodes, whose spore-producing lamellae were exposed to the sun. Dried mushrooms also elicited vitamin D production subsequent to sunlight exposure.

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  4. Jeez... publishing before even doing it. I also have some examples from RA that are getting on my nerves. At least this one plans to measure some sort of outcome, the RA ones don't measure anything just plan a "great project"... yeek

    And back to this vit. D trial. For my simple mind it looks somewhat underpowered if the outcome is relapses.

    J

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    Replies
    1. Yeah, clinicians get several publications for the same piece of work. A major sore point to us non-clinicians. If I get these, what we're gonna do papers to referee, I reject them, with a "show me the data" comment, I wish others would too.

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  5. " I wonder how natural sunlight exposure will influence this I guess people in North with get low and high dose and people in south will get low and high doses I guess it adds "noise" into the system. "

    By having a control group in the same geographic locations (like-for-like)

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  6. I've been taking 10,000 units D3 for almost two years and my blood levels remain in the normal range when tested for Vitamin D and though I believe that it does help I do not feel that it makes a tremendous amount of overall difference in the long run! Just my experience along these lines.

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  7. There's going to be a few interesting studies regarding vit D. I wonder if some of the doses mentioned in the studies are too high.

    A larger study (approximately 300 participants) plans to investigate whether vitamin D supplements (100,000 IU every 2 weeks, equivalent to 7000 IU/day) for up to 2 years will reduce the risk of conversion from CIS to full MS31. The study is expected to finish in June 2017.

    The PrevANZ study in Australia and New Zealand (160 participants initially) will test whether daily doses of 1000, 5000 and 10000 IU vitamin D or placebo for 48 weeks after a first episode of symptoms can prevent or delay the time to a definite diagnosis of MS32. Results of this study are also expected in 2017.

    http://www.mstrust.org.uk/information/publications/factsheets/vitamind.jsp

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    Replies
    1. Here's some direct links to a bit more info on the Australian PreANZ Vit D trial:
      http://www.menzies.utas.edu.au/article.php?Doo=ContentView&id=1512
      http://www.menzies.utas.edu.au/article.php?Doo=ContentView&id=1551
      http://www.msra.org.au/prevanz

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  8. I have been in a similar test few years ago connected with betaferon and the result was that patients with placebo had more relapses thant the other using "high" doses of Vitamin D. Shame...its just 5,000IU daily. Its already well known that everyone,even healthy people should use at least that much in Winter. They should try 10,000IU daily. And check if its the limit..

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  9. I use 10,000IU daily without any disease :)

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  10. My name is Ricardo, I'm from Brazil, now I'm 42 years old, and I discovered MS with 24 (since 1996), I took Betaseron, Rebif, Avonex, and finally Copaxone. Now I'm on Vitamin D and Omega 3, and stopped with all other medications. I'm felling great, it's another life, without those injections and the bad feeling every day. Now I'm almost normal again!!!

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    Replies
    1. I am happy that these work for you but they are nutriceuticals without ompelling evidence for efficasy

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    2. Dear MouseDoctor, I think that Ricardo is following Prof. Coimbra lineguides.
      He is curing MS in Brazil with high dose Vitamin D only.
      Seems there are a lot of Brazilians experiencing extreme benefits from this approach.....
      If you do a Google Search about Coimbra, you can find a lot of informations.

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    3. The notion that MS is being cured with nothing more than high dose vitamin D is dubious in the extreme. I've done a quick PubMed search and other than blog sites, Prof Coimbra seems to have published nothing to back up these claims in MS and until he does these claims should be viewed with extreme caution.

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  11. Current evidence clearly indicates that some Vitamin D controlled genes are involved in the development of MS and that Th17 is involved in symptom variation. Recent studies are pointing very clearly that at least 10,000iu daily is required to make a difference to symptoms. That dose will most certainly alter levels of Th17 thereby modulating some of the immune components of MS. In addition 10,000iu daily is safe.

    Any study, and there are many of them around the world at the moment using less than 10,000 iu daily will report little or no effect of vitamin D on MS. The results of these studies will leave no better off, except to say that doses less than 10,000 daily have little or no effect. What a waste of resources and an inevitable delaying of further research because of heightened skepticism.

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