Effects of vitamin D on retinal nerve fiber layer in vitamin D deficient patients with opticneuritis: Preliminary findings of a randomized, placebo-controlled trial

There is accumulating evidence for a possible protective role of vitamin D in the development and disease course of multiple sclerosis. Whether vitamin D is also effective in treating patients with optic neuritis (ON) is not known. The aim of this study was to evaluate the effect of oral vitamin D on the thickness of retinal nerve fiber layer (RNFL) in vitamin D deficient patients with ON by optical coherence tomography. A Phase II placebo-controlled randomized clinical trial conducted between July 2011 and November 2012 included 52 patients with confirmed unilateral ON aged 15-38 years and low serum 25-hydroxyvitamin D levels. The main outcome measures were changes in thickness of RNFL and macula 6 months after treatment. Patients were randomly allocated to receive 6 months of treatment with adding either 50,000 IU/ week vitamin D or placebo. In the 27 patients treated with vitamin D, the mean (standard deviation [SD]) thickness of RNFL decreased from 111.3 (18.9) μm at baseline to 91.4 (13.3) at the end of study period (P < 0.001). Correspondingly, in the 25 patients treated with placebo, the mean (SD) thickness of RNFL decreased from 11. (21.5) μm at baseline to 96.1 (12.3) at the end of study period (P < 0.01). In both groups, the mean thickness of the macula did not changed (P > 0.05). Average thickness of RNFL at the end of trial did not differ between groups. Adding vitamin D to routine disease therapy had no significant effect on the thickness of RNFL or macula in patients with ON. This trial is registered on www.clinicaltrials. gov (ID NCT01465893).