Investigating the effects of 25-hydroxyvitamin D3 on clinical outcomes in multiple sclerosis patients: A randomized, double-blind clinical trial- a pilot study.
Level 2 - randomized trial
Randomized, double-blind, active-controlled trial
PubMed 38759424 · doi:10.1016/j.msard.2024.105673
What was done
A randomized, double-blind pilot clinical trial compared daily oral calcifediol (25(OH)D3, 50 μg, n=25) against daily oral cholecalciferol (50 μg, n=25) in 50 patients with multiple sclerosis. Measured outcomes included serum 25(OH)D3 concentrations, number of relapses, Expanded Disability Status Scale (EDSS) scores, 25-foot walk test, cognitive function, quality of life, and fatigue.
What was found
Delta serum 25(OH)D3 concentrations were 85.32 ± 40.94 ng/ml in the calcifediol group versus 13.72 ± 11.56 ng/ml in the cholecalciferol group; 84% of calcifediol participants achieved concentrations >70 ng/ml versus 0% with cholecalciferol. The calcifediol arm showed greater improvements across most cognitive function tests compared to cholecalciferol. Neither treatment group demonstrated significant beneficial effects on MS relapse rates, EDSS scores, quality of life, or fatigue.
Why it matters
This study demonstrates that calcifediol increases circulating 25(OH)D3 levels substantially more effectively than equimolar cholecalciferol in MS patients and suggests potential cognitive benefits, though hard clinical disability endpoints remained unchanged.
Limits
The sample size was small (n=50 total, 25 per arm), limiting statistical power for clinical endpoints like relapses and disability progression. Study duration, baseline characteristics, and exact numeric scores for cognitive and disability outcomes were omitted from the abstract.
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- context Rayaldee is a pre-activated vitamin D prescribed for multiple sclerosis.