Multiple Sclerosis News TodayHigh-dose Vitamin D May Stop CIS, Early RRMS New Disease Activity

This Phase 3 trial (D-Lay-MS, NCT01817166) investigated high-dose vitamin D3 (cholecalciferol) in clinically isolated syndrome (CIS) and early RRMS. The study showed statistically significant reduction in disease activity with biweekly 100,000 IU oral supplementation compared to placebo over a two-year period, particularly in delaying time to new disease activity.

⚕️Key Clinical Considerations⚕️

• High-dose vitamin D3 (100,000 IU biweekly) reduced risk of disease activity by 34% compared to placebo in both CIS and early RRMS patients according to 2017 McDonald Criteria.
• Time to new disease activity was nearly doubled in the vitamin D group (432 days vs 224 days), with significant reductions in MRI activity markers.
• No significant differences were observed in relapse rates (17.9% vs 21.8%) or measures of disability, fatigue, depression, anxiety, or quality of life.
• Patients most likely to benefit had severe vitamin D deficiency at baseline, normal BMI, and no spinal cord lesions.
• Treatment was generally safe and well-tolerated, potentially offering an inexpensive therapeutic option with low adverse event risk.

🎯 Clinical Practice Impact 🎯

• Patient Communication: Discuss vitamin D supplementation with CIS and early RRMS patients not currently on DMTs, especially those with severe deficiency and normal BMI. Explain that although vitamin D may delay disease activity, evidence doesn’t show improvement in symptoms, disability progression, or quality of life measures.
• Practice Integration: Consider vitamin D monitoring and supplementation as part of standard care for newly diagnosed CIS/early RRMS patients. The treatment effect size was comparable to some DMTs in CIS, making it potentially valuable for patients with limited access to conventional therapies.
• Action Items: (1) Assess baseline vitamin D levels in newly diagnosed CIS/RRMS patients. (2) Evaluate candidates for high-dose supplementation based on favorable profile: vitamin D deficiency, normal BMI, and absence of spinal cord lesions.

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