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Preventive effect of vitamin D3 supplementation on conversion of optic neuritis to clinically definite multiple sclerosis: a double blind, randomized, placebo-controlled pilot clinical trial


Multiple sclerosis (MS) presents with optic neuritis (ON) in 20 % of cases and 50 % of ON patients develop MS within 15 years. In this study, we evaluated the preventive effects of vitamin D3 administration on the conversion of ON to MS (primary outcome) and on the MRI lesions (secondary outcome) of ON patients with low serum 25 (OH) D levels. Thirty ON patients (15 in each of 2 groups, aged 20–40 years) with serum 25 (OH) D levels of less than 30 ng/ml were enrolled in a double blind, randomized, parallel-group trial. The treatment group (cases) received 50,000 IU of vitamin D3 weekly for 12 months and the control group (controls) received a placebo weekly for 12 months. Finally, the subsequent relapse rate and changes in MRI plaques were compared between the two groups. Risk reduction was 68.4 % for the primary outcome in the treatment group (relative risk = 0.316, p = 0.007). After 12 months, patients in the treatment group had a significantly lower incidence rate of cortical, juxtacortical, corpus callosal, new T2, new gadolinium-enhancing lesions and black holes. The mean number of total plaques showed a marginally significant decrease in the group receiving vitamin D3 supplementation as compared with the placebo group (p = 0.092). Administration of vitamin D3 supplements to ON patients with low serum vitamin 25 (OH) D levels may delay the onset of a second clinical attack and the subsequent conversion to MS.

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The authors are very grateful to the patients and their relatives for their collaboration with this research. This survey was conducted by the cooperation of Isfahan University of Medical Sciences (IUMS) and Isfahan Multiple Sclerosis Society (IMSS). The project was supported by IUMS [Grant number: 291041] and SHARNOS research Co. (Knowledge of vision and motion). Also, a specific research grant has been received from CinnaGen Inc. The results of this study are dedicated to the memory of Dr. Afsane Khandan (Iranian internist) who devoted her precious life to knowledge, health development, and, medical research.

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The authors have no proprietary interest in the materials presented herein.

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Correspondence to Seyed-Hossein Abtahi.

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Clinical trial registration number: IRCT201205319919N1.

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Derakhshandi, H., Etemadifar, M., Feizi, A. et al. Preventive effect of vitamin D3 supplementation on conversion of optic neuritis to clinically definite multiple sclerosis: a double blind, randomized, placebo-controlled pilot clinical trial. Acta Neurol Belg 113, 257–263 (2013).

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  • Multiple sclerosis
  • Optic neuritis
  • Vitamin D3
  • 25 (OH) D
  • Clinical trial
  • Isfahan, Iran