Table 1 Clinical trials on vitamin D for MS treatment
From: Iranian consensus on use of vitamin D in patients with multiple sclerosis
First author, date | Method | Participants | Intervention | Neurological/clinical measures | Neurological/clinical result |
|---|---|---|---|---|---|
Burton, 2010 [58] | open-label randomized prospective controlled 52-week trial | MS patients 18–55 years mean EDSS: 1.34 Treatment group/control (n): 24/23 | -Treatment: Increasing vitamin D3 dose up to 40,000 IU/d for 28 weeks, followed by 10,000 IU/d for 12 weeks, downtitrated to 0 IU/day plus 1200 mg calcium/d throughout the study -Control: = < 4000 IU vitamin D3/day and calcium if needed | EDSS, serum calcium level | No significant difference in relapse rate |
Kampman, 2012 [59] | Randomized double-blind controlled 96-week trial | MS patients 18–55 years EDSS ≤ 4.5 Treatment group/control (n): 35/33 | -Treatment: 20,000 IU vitamin D3/week, plus 500 mg calcium/day -Control:500 mg calcium/day | annual relapse rate, MSFC, EDSS, fatigue and grip strength | No significant difference in annual relapse rate, MSFC, EDSS, fatigue and grip strength |
Shaygannejad, 2012 [60] | Randomized double-blind controlled 12-month trial | RRMS 15–60 years EDSS ≤ 6 Serum 25(OH)D > 40 ng/ml; and willing to continue vitamin D supplementation Treatment group/control (n): 25/25 | -Treatment: 0.25 mcg calcitriol/day increased to 0.5 mcg/d after 2 weeks -Control: placebo | Relapse rate and EDSS | No significant difference in relapse rate and EDSS |
Soilu-Hänninen, 2005 [61] | Randomized double-blind controlled 1-year trial | RRMS 18–55 years EDSS ≤ 5 Treatment group/control (n):34/32 | -Treatment: 20,000 IU vitamin D3/week -Control: placebo (with interferon β-1b use) | EDSS, relapse rate, timed 10 foot tandem walk test, timed 25 foot walk test, brain MRI | Significant reduction in the number of T1 enhancing lesions and EDSS in treatment group No significant reduction in relapse rate |
Stein, 2011 [62] | Randomized double-blind controlled 24-months trial | RRMS >18 years Treatment group/control (n): 11/12 | Treatment:6000 IU vitamin D2 twice daily +1000 IU vitaminD2 daily Control:1000 IU vitamin D2 daily + placebo | MRI, relapse rate, EDSS | No significant difference in MRI findings. Follow-up EDSS was higher following high dose D2 (after adjusting for baseline EDSS), relapse rate was significantly higher in high dose group |
Ongoing trials | |||||
 Clinicaltrials.gov identification number | Duration | Estimated enrollment | Intervention |  |  |
 NCT01198132 | 96 weeks | 250 | Treatment: 100,000 IU vitamin D3/month + 3 rebif/week Control: 3 rebif/week |  |  |
 NCT01490502 | 104 weeks | 172 | Treatment: 5000 IU vitamin D3/day + Copaxone Control: 600 IU vitamin D3/day + Copaxone |  |  |
 NCT01024777 | 26 weeks | 40 | Treatment: 10,000 IU vitamin D3/day Control: 400 IU vitamin D3/day |  |  |
 NCT01285401 | 96 weeks | 358 | Treatment: 6670 IU vitamin D3/day for 4 weeks, 14,007 IU vitamin D3/day for the following 92 weeks + 3 Rebif /week Control: 3 Rebif /week |  |  |
 NCT01440062 | 78 weeks | 80 | Treatment: 20,400 IU vitamin D3 on alternate day + Interferon ß-1b Control: 400 IU vitamin D3 on alternate day + Interferon ß-1b |  |  |