Table 1.
Clinical trials with vitamin D supplementation
| Type of study | Patients | Dose | Period | Effect |
|---|---|---|---|---|
| Double-blind design study | 17 patients | 1000 IU/d | 6 mon | Increased serum TGF-β1 levels |
| Phase I/II randomized trial (Completed) | 15 pregnant patients | 50000 IU/wk | 12 to 16 wk | Fewer relapse events and unchanged EDSS |
| Clinical trial (Completed) | 40 RRMS patients | 10400 IU or 800 IU/d | 6 mon | Reduction in the proportion of IL-17+ CD4+ cells, CD161+ CD4+ cells, and effector memory CD4+ cells in high-dose group |
| Phase 3 FREEDOMS and FREEDOMS II trials (Completed) | 1953 patients | Not registered | 674.5 ± 181.61 d | Improved MRI on brain volume and patients free of T2 lesions |
| Clinical trial (Terminated) | RRMS female patients | 4000 IU/d | 16 wk | Decreased TNF-α concentration in culture supernatants of CD3+CD4+ cells |
| Clinical trial (Completed) | 53 RRMS patients | 14000 IU/d | 48 wk | Decreased Treg CD25-expression and circulating soluble-CD25 levels period |
| Clinical trial CHOLINE (Completed) | RRMS patients with low serum VitD and therapy with IFN-β-1a | 100000 IU every other week | 96 wk | ARR reduction, less new T1-weighted lesions, lower volume of T1-weighted lesions, and a lower EDSS period |
| Clinical trial SOLAR (Completed) | RRMS patients with low serum VitD and therapy with IFN-β-1a | 14007 IU/d | 48 wk | Protective effects on development of new MRI lesions |
| Clinical trial BENEFIT (Completed) | 278 patients with clinically isolated syndrome | 50 nM | 2 yr | 65% lower odds of poorer PASAT-3 |
ARR: Annualized relapse rate; CD: cluster of differentiation; d: daily; EDSS: expanded disability status scale; IFN: interferon; IL-17: interleukin-17; IU: international unit; MRI: magnetic resonance imaging; PASAT-3: paced auditory serial addition test-3; RRMS: Relapsing Remitting Multiple Sclerosis; TGF: transforming growth factor; TNF: tumor necrosis factor; Treg: regulatory T cells; VitD: vitamin D; mths: months; wk: week; yr: year.