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

Abstract

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.

Vitamin D in Autoimmunity: Molecular Mechanisms and Therapeutic Potential

“…On the other hand, two other trials reported no difference in any of these parameters (50, 52). Vitamin D supplementation might also be important in the pre-MS stage, since cholecalciferol supplementation decreased the conversion rate of optic neuritis to chronic MS (53). …”

Narrowband UVB Phototherapy for Clinically Isolated Syndrome: A Trial to Deliver the Benefits of Vitamin D and Other UVB-Induced Molecules

“…With respect to prevention of MS, there have been two previous studies. The first was a randomized controlled trial in Iran of 30 optic neuritis patients given 50,000 IU vitamin D 3 per week for 12 months (24). There were significantly fewer cases of a second demyelinating attack measured on MRI in the treated group.…”

“…The authors evaluated the clinical effectiveness of vitamin D supplementation in four systematic reviews (27–30), eight randomized controlled trials (24, 31–37), and three non-randomized studies (25, 38, 39). The authors of the CADTH Rapid Report concluded that “the outcomes of vitamin D supplementation for MS were heterogeneous, conflicting and inconsistent, with no effect on disability scores and relapse rates.…”

Radiologically isolated syndrome and clinically isolated syndrome

“…A recent systematic review and meta‐analysis included the following eligible placebo‐controlled randomized clinical trials of patients with CIS: the Early Treatment of Multiple Sclerosis study (ETOMS), the Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis in Subjects Presenting with a Clinically Isolated Syndrome study (PreCISe) and the Oral Teriflunomide for Patients with a First Clinical Episode Suggestive of Multiple Sclerosis study (TOPIC); the results of this meta‐analysis showed that DMD including interferon β‐1a SC, glatiramer acetate and teriflunomide appear to attenuate brain atrophy over time when compared with placebo in patients with CIS . As discussed earlier, low vitamin D levels could be a risk factor for the conversion from CIS to clinically definite MS, and a small randomized control trial has suggested that vitamin D supplementation might reduce the risk of developing MS after CIS …”

“…42 As discussed earlier, low vitamin D levels could be a risk factor for the conversion from CIS to clinically definite MS, and a small randomized control trial has suggested that vitamin D supplementation might reduce the risk of developing MS after CIS. 48 As with RIS earlier, there is a question about whether treatments with DMD for patients with CIS should be initiated as early as possible. Randomized, placebo-controlled trials were carried out to evaluate the use of interferon b, [49][50][51][52] glatiramer acetate, 53 teriflunomide 47 and cladribine 54 for patients with CIS at high risk of developing clinically definite MS as defined by MRI criteria (Table 4).…”