Failed vitamin D trial..Failed to infrom:-(
ProfG has done a post on medical fiction. It is perhaps approriate to do a post on science fiction.
As you know scientists are like sheep and they herd together and follow one and other. They stick close to the “dogma machine” and follow trends because, this is where money gets put. I have gone on the record of discussing a few. Some I have discussed way before they have become main stream. Yep another reason why I do myself no favours. But five minutes of thought, may have saved millions of dollars expanding veins and sometimes people are pulled in to respond to public pressure.
Now that idea was medical fiction, it created an industry of science fiction and about one animal paper, but how many studies were funded on the back of this idea?
ProfG is on a mission to prevent MS and you can look at aetiological risk factors and Vitamin D popped up.
The Dogma machine churned and every one got on the bandwagon clamouring to do clinical trials on vitamin D. So if we look on clinical trials.gov, we see 1,733 studies and look at MS and we have 25. We are all stuffing our face with vitamin D tablets, including me, to make sure we are vitamin D replete. ProfG always says help maintain the bone health.
Now should I carry on and put me and the Team in hot water with our peers or should I give up with this contensious stuff so you can have light and fluffy?
Seriously, this is a very real question.
It is an internal discussion we have and have to keep having and one day it will close us down for good. I was off last week!
So here is an example
Will taking vitamin D tablets stop your MS….I think I can confidently say No. Others will say we don’t know so let’s do the study. I buy into that, but it does not say I can’t have opinons on likihood of succes.
There are so many people munching the stuff if there was a miraculous cure…we would know it. ProfG would argue that the biology suggests that the effect is likely to be earlier in life before MS shows itself and I buy that too and trials should be preventative and not reactive, but is vitamin D a DMT?
Again I would say it is not good enough to have a major impact.
Because you can’t have it both ways!
If it is going to be a potent immunosuppressive to get rid of existing MS, it is going to come with the side effects of removing important parts of your immune system. So infections and cancers can occur.
There is no brain power here, it is just Dr. Spock
Taking vitamin D is relatively innocuous…therefore you have the answer. Two minutes of thought verses millions of dollars spent on trials, which at worst will show nothing and at best show something marginal.
Could it have add-on benefit?
Now marginal may be a good thing because it helps keep every thing under control and it adds to the benefit of more effective treatment but to think it is going to be better than an effective DMT, is not to think. This view however, gets me into trouble because many of my colleagues have jumped on the badwagon and many charities and governments across the spectrum of medical biology have sunk money into this. Now I think I can exclude the MS Society in UK from this one as I am not sure they bit on the idea of trials. But as I say. I do myself no favours.
However, if the science is wrong, we are like lemmings rather than sheep and we run off the end of the cliff one after the other.
Again I ask. Should I stop doing this? It does us no favours.
So today we have this.
High-dose vitamin D supplementation in multiple sclerosis – results from the randomized EVIDIMS (efficacy of vitamin D supplementation in multiple sclerosis) trial. Dörr J, Bäcker-Koduah P, Wernecke KD, Becker E, Hoffmann F, Faiss J, Brockmeier B, Hoffmann O, Anvari K, Wuerfel J, Piper SK, Bellmann-Strobl J, Brandt AU, Paul F.Mult Scler J Exp Transl Clin. 2020 Jan 24;6(1):2055217320903474.
BACKGROUND: Epidemiological, preclinical, and non-interventional studies link vitamin D (VD) serum levels and disease activity in multiple sclerosis (MS). It is unclear whether high-dose VD supplementation can be used as an intervention to reduce disease activity.
OBJECTIVES:The study aimed to compare the effects of every other day high- (20,400 IU) versus low-dose (400 IU) cholecalciferol supplementation on clinical and imaging markers of disease activity in patients with relapsing-remitting MS or clinically isolated syndrome.
METHODS:The EVIDIMS (efficacy of vitamin D supplementation in multiple sclerosis) trial was a multicentre randomized/stratified actively controlled explorative phase 2a pilot trial with a double-blind intervention period of 18 months, add on to interferon-β1b.
RESULTS:Fifty-three patients were randomized, and 41 patients completed the study. Cholecalciferol supplementation was well tolerated and safe in both arms. After 18 months, clinical (relapse rates, disability progression) and radiographical (T2-weighted lesion development, contrast-enhancing lesion development, brain atrophy) did not differ between both treatment arms. Post-study power calculations suggested that the sample size was too low to prove the hypothesis.
CONCLUSIONS:The results neither support nor disprove a therapeutic benefit of high-dose VD supplementation but provide a basis for sound sample size estimations in future confirmatory studies.
A sample size of 80 patients (40 in each arm) was planned, based mainly on feasibility. After starting recruitment, the study was terminated early. Fifty-three patients were randomized and included in the intention to treat anlyses, 28 in the high-dose and 25 in the low-dose arm . To detect a difference in the T2w lesion count with a power of 80% and a type 1 error (α) of 0.05 (two-sided) 252 participants (PP population) or 613 (ITT population) per arm would be necessary. The corresponding numbers for the hypothetical endpoint T2w lesion volume would be 3147 or 33,202 participants per arm. These power considerations suggest the in principle feasibility to demonstrate (or disprove) a disease-modifying effect of vitamin D supplementation in MS patients, at least for the endpoint T2w lesion count.
So the study was not big enough to get a definative answer and will have to be done again. OK you have to do a study to work out how bit a study needs to be to get an answer and the answer is….it needs to be big. Will it get done to have 33,202 per arm? The answer is no. You have to rely on registry data.
It does not say that taking vitamin D no merit.
I ask what does it do on memory B cells? Yep the idea is not refuted based on the data I have seen and more evidence this is a better path to follow.