High-dose vitamin D₃ supplementation in relapsing-remitting multiple sclerosis: a randomised clinical trial

Area of Science:

• Neurology
• Immunology
• Endocrinology

Background:

• Vitamin D insufficiency is linked to multiple sclerosis (MS) relapse risk.
• The effect of vitamin D supplementation on MS prognosis remains unclear.
• The VIDAMS trial investigated high-dose vitamin D3 alongside glatiramer acetate (GA) in RRMS patients.

Purpose of the Study:

• To determine if high-dose vitamin D3 (5000 IU/day) versus low-dose (600 IU/day) reduces clinical relapse risk in relapsing-remitting MS (RRMS) patients over 96 weeks.
• To assess the safety of high-dose vitamin D3 supplementation in RRMS patients.

Main Methods:

• A randomized, double-blind, multi-center, phase 3 trial (VIDAMS) involving 172 RRMS participants.
• Participants received either low-dose (LDVD) or high-dose (HDVD) vitamin D3 plus daily GA.
• Primary outcome was the proportion of participants experiencing a confirmed relapse over 96 weeks.

Main Results:

• No significant difference in confirmed relapse rates between LDVD and HDVD groups (32% vs. 34%, p=0.60).
• Hazard ratio for relapse was 1.17 (0.67, 2.05), p=0.57.
• No cases of hypercalcemia were reported; three participants experienced kidney stones, with two possibly related to study drug.

Conclusions:

• High-dose vitamin D3 supplementation, when added to GA, does not reduce clinical relapse risk in RRMS patients.
• These findings, consistent with previous trials, suggest that higher vitamin D doses may not be beneficial for modifying the RRMS disease course.