A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis.
Level 2 - randomized trial
Randomized controlled trial (Phase I/II)
PubMed 20427749 · doi:10.1212/WNL.0b013e3181e1cec2
What was done
An open-label randomized prospective controlled 52-week phase I/II trial in 49 patients with multiple sclerosis (MS) matched for demographic and disease characteristics. Patients were randomized to treatment (n = 25) or control (n = 24). The treatment group received escalating oral vitamin D3 doses up to 40,000 IU/day over 28 weeks, followed by 10,000 IU/day for 12 weeks, and then downtitrated to 0 IU/day. Both groups received calcium (1,200 mg/day) throughout. The primary endpoint was change in serum calcium and comparison between groups; secondary endpoints included 25(OH)D levels, immunologic biomarkers, relapses, and Expanded Disability Status Scale (EDSS) scores.
What was found
Baseline characteristics across all 49 patients included a mean age of 40.5 years, mean EDSS of 1.34, and baseline serum 25(OH)D of 78 nmol/L. Despite a mean peak 25(OH)D of 413 nmol/L in the treatment group, all calcium-related measures remained normal within and between groups, and no significant adverse events occurred. The treatment group appeared to have fewer relapse events and a persistent reduction in T-cell proliferation compared to controls, though the abstract reports no exact numerical values, effect sizes, or p-values for clinical or immunologic outcomes.
Why it matters
This study demonstrates that high-dose vitamin D3 (up to 40,000 IU/day tapering to 10,000 IU/day) co-administered with calcium is safe and does not cause hypercalcemia in MS patients, while showing potential immunomodulatory activity that warrants larger efficacy trials.
Limits
The study was open-label with a small sample size (n = 49). As noted by the authors, the trial lacked statistical precision and design features necessary to evaluate clinical efficacy (EDSS and relapse rates), and specific numerical data for clinical and immunologic endpoints were not reported in the abstract.
Cited by
- supports In certain autoimmune disease protocols, monitored vitamin D blood levels are pushed up to 200 ng/mL.