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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
  
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