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. Author manuscript; available in PMC: 2012 Dec 1.
Published in final edited form as: Mult Scler. 2011 Oct 13;17(12):1405–1411. doi: 10.1177/1352458511425366

Table 3.

Currently ongoing vitamin D treatment trials among MS patients

Randomized Clinical Trials
SOLAR The effects of IFN beta
combined with vitamin D
on relapsing-remitting
multiple sclerosis patients		 CHOLINE Cholecalciferol as an add-
on treatment to
subcutaneously
administered IFN beta-1b
for treatment of MS
Locations Europe (Belgium, Denmark,
Estonia, Finland, Germany,
Hungary, Latvia, Lithuania,
Norway, Switzerland, The
Netherlands, Italy)		    Israel    France    Finland
Study dates   2/2011–2/2012   10/2010–10/2011   1/2010–12/2013   3/2008–6/2011
Target enrollment     348     100     250     70
Age at recruitment    18–50    18–65    18–65    18–55
Treatment Arms Active: IFN beta-1a 44 ug sc
3x/wk + 7,000 IU/d
cholecalciferol 4 weeks
escalating to 14,000 IU/d 92
weeks non-active: IFN beta-1a
44 ug sc 3x/wk +placebo		 Active: 800 IU/d
cholecalciferol + 75,000 IU
cholecalciferol every 3
weeks
non-active: 800 IU/d
cholecalciferol +placebo
solution every 3 weeks		 Active: IFN beta-1a 44 ug
sc 3x/wk + 100,000 IU
cholecalciferol 2x/mo
non-active: IFN beta-1a
44 ug sc 3x/wk +placebo		 Active: 20,000 IU/week
cholecalciferol
non-active: once weekly
placebo
Endpoints Primary: mean number of
combined unique active lesions
on MRI at week 48; proportion
of relapse free patients at 96
weeks; Secondary: proportion of
relapse free patients at 46 weeks;
time to first relapse; relapse rate		 Primary: occurrence and
severity of IFN beta related
flu-like symptoms and
injection site reactions.
Secondary: EDSS
progression, relapse rate,
immunological changes		 Primary: reduction in
relapse rate Secondary:
time to first relapse, mean
number of relapses per
subject, per year; new
lesions on MRI		 Primary: proportion of
patients with P-PTH
<20ng/l and 25(OH)D >
85nmol/L at 6 and 12
months; Secondary:
number of Gd+ lesions or
new lesions at 12 months
vs.baseline
Duration 96 weeks 52 weeks 96 weeks 52 weeks
Trial number NCT 01285401 NCT01005095 NCT01198132 NCT01339676
*

SOLAR: Supplementation of Vigantol® oil versus placebo as add-on in patients with relapsing-remitting multiple sclerosis receiveing Rebif® treatment

CHOLINE: A multicentre, randomized, double-blind, placebo-controlled Study of the Efficacy of Supplementary Treatment with Cholecalciferol in Patients with Relapsing-Remitting Multiple Sclerosis Treated with Subcutaneous Interferon Beta-1a 44 ug 3 times weekly

†

target enrollment