53 Multiple Sclerosis patients somewhat helped by 10,000 IU of vitamin D (vs, 30,000 virtually cured by 10X as much)

High-dose vitamin D supplementation in multiple sclerosis – results from the randomized EVIDIMS (efficacy of vitamin D supplementation in multiple sclerosis) trial

J Multiple Sclerosis Journal – Experimental, Translational and Clinical, https://doi.org/10.1177/2055217320903474

an Dörr†, Priscilla Bäcker-Koduah, Klaus-Dieter Wernecke, ...

This EVIDIMS Randomized Controlled trial used 20,400 IU of Vitamin D every second day Some success was achieved (see table below) --- Dr. Coimbra's protocol customizes the treatment for each MS patient     Thus it cannot be run as a Randomized Controlled Trial Vitamin D is not a single magic bullet - many other nutrients are used One (dose) size does not fit all - The Coimbra Protocol uses 2X to 15X as much vitamin D --- 1. MS References in VitaminDWiki – Dec 2019 {include} --- 1. Table compares 4 High-dose vitamin D therapies

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Portion of table in the PDF

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. www.clinicaltrials.gov/NCT01440062