A Randomised, Double-Blind, Placebo-Controlled Trial with Vitamin D3 in MS: Subgroup Analysis of Patients with Baseline Disease Activity Despite Interferon Treatment

Abstract

We present a subgroup analysis of the first double-blind, placebo-controlled, randomised trial with vitamin D3 in MS. In the overall study population, there were 34 patients in the vitamin D arm and 32 patients in the placebo arm. All the patients were using interferon-β-1b (IFNB) therapy. The subgroup consisted of 15 patients in the vitamin D arm and 15 patients in the placebo arm, who had either at least one relapse during the year preceding the study or enhancing T1 lesions at the baseline MRI scan. We measured the total number of MRI T1 enhancing lesions, the number of new/enlarging T2 lesions and T2 lesion volume (BOD) (mm3), EDSS (Expanded Disability Status Scale), annual relapse Rate (ARR), timed 25-foot walk (T25FW), and timed 10-foot tandem walk (TT10W) at baseline and at 12 months in the vitamin D-treated and in the placebo-treated patients. There was a statistically significant reduction in the number of T1 enhancing lesions, a smaller T2 lesion volume growth and less new/enlarging T2 brain MRI lesions in the vitamin D3-treated than in the placebo-treated subgroup patients. The MRI results were slightly more pronounced in the subgroup than in the overall study population.

Does vitamin D have protective effect on human nasal polyposis: histological and immunohistochemical study

“…Also the nasal polyps before VD taking in the present study showed damage of respiratory epithelium that rests on thick basal lamina with numerous inflammatory cells infiltration, extensive accumulation of collagen fibers in lamina propria and highly expressed TLR-9 and these results were agreed with [23][24][25] who reported that the histological appearance of NP is characterized by respiratory epithelium with a range of mucosal alterations that include ulceration, thickening of the basement membrane, near normal nasal mucosa with overcrowded respiratory epithelium rests on apparently thin basal lamina and lamina propria of loose connective tissue with few cells infiltration and many blood vessels and showed significant decrease (P<0.05) in all symptoms of VAS score and endoscopic appearance of Lund and Mackey score and the mean area % of submucosal accumulation of collagen fibers and TLR-9 expression while this decrease was insignificant (P < 0.05) in the low dose VD group (IIa). These results agreed with [39] who reported that the antiproliferative effects of VD were dose-and timedependent, the lower concentration used was mostly without any effect and [40] stated that in the overall study population of Finnish VD Study, clinical outcomes appeared to favor the high-dose VD group. Also Allen et al, reported that high dose VD (5000-10,000 IU/day) has immunomodulatory and anti-inflammatory effects through increasing interleukin-10 (IL-10) production by peripheral blood mononuclear cells and a reducing frequency of T helper 17 cells (Th17) cells and Kimball et al, reported that high doses of VD may be required for therapeutic efficacy and tolerability.…”

Vitamin D3 administration to MS patients leads to increased serum levels of latency activated peptide (LAP) of TGF-beta

“…The percentages of patients with adverse event including upper respiratory tract infections and other mild infections did not differ between the treatment and the placebo arms. The clinical and MRI results of the Finnish Vitamin D Study have been published previously (Åivo et al, 2012;Soilu-Hänninen et al, 2012),…”

“…A prospective study has suggested an inverse relationship with increasing vitamin D levels and new MRI lesions (Mowry et al, 2012). In a RCT focused on safety and radiological endpoints, we previously showed that vitamin D supplementation at a weekly dose of 20,000 IU significantly decreased gadolinium enhancing lesions on brain MRI compared to placebo (Åivo et al, 2012;Soilu-Hänninen et al, 2012). In a recent Italian study in patients with CIS, low levels of vitamin D were associated with increased MS risk (Martinelli et al, 2014).…”

“…The design and the results of the study have been reported previously (Åivo et al, 2012;Soilu-Hänninen et al, 2012). All patients gave written informed consent separately to the immunogenetic substudy described in this paper.…”

Therapeutic and Prophylactic Potential of Vitamin D for Multiple Sclerosis

“…However, it is not known whether supplementation has a significant impact on MS progression. A clinical trial (NCTO1339676) employing oral supplementation with active VitD (20,000 IU/week, cholecalciferol, Dekristol) administered once a week during 12 months together with IFN-β-1b resulted in reduction of MRI lesions in the brain of MS patients [78]. In another clinical trial (NCT 00785473), this same dose (20,000 IU/ week, cholecalciferol, Dekristol) was administered during 24 months in RRMS patients under treatment with IFN-β-1b, GA, or natalizumab.…”