Efficacy of vitamin D3 as add-on therapy in patients with relapsing–remitting multiple sclerosis receiving subcutaneous interferon beta-1a: A Phase II, multicenter, double-blind, randomized, placebo-controlled trial

Smolders, Joost; Hupperts, Raymond; Barkhof, Frederik; Grimaldi, Luigi M. E.; Holmøy, Trygve; Killestein, Joep; Rieckmann, Peter; Schluep, Myriam; Vieth, Reinhold; Hostalek, Ulrike; Ghazi-Visser, Lizette; Beelke, Manolo

doi:10.1016/j.jns.2011.04.013

Cited by 108 publications

(82 citation statements)

References 34 publications

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“…Randomized controlled trials are currently underway to examine the effects of vitamin D supplementation on clinical and radiologic outcomes, with dosages of 5,000 to 10,000 IU daily. [23][24][25] …”

Section: High-dose Vitamin D Treatment Results In a Decrease In The Cmentioning

confidence: 99%

Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis

et al. 2016

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Objective: To study the safety profile and characterize the immunologic effects of high-vs low-dose cholecalciferol supplementation in patients with multiple sclerosis (MS).Methods: In this double-blind, single-center randomized pilot study, 40 patients with relapsingremitting MS were randomized to receive 10,400 IU or 800 IU cholecalciferol daily for 6 months. Assessments were performed at baseline and 3 and 6 months.Results: Mean increase of 25-hydroxyvitamin D levels from baseline to final visit was larger in the high-dose group (34.9 ng/mL; 95% confidence interval [CI] 25.0-44.7 ng/mL) than in the lowdose group (6.9 ng/mL; 95% CI 1.0-13.7 ng/mL). Adverse events were minor and did not differ between the 2 groups. Two relapses occurred, one in each treatment arm. In the high-dose group, we found a reduction in the proportion of interleukin-17T cells (p 5 0.03), and effector memory CD4 1 T cells (p 5 0.021) with a concomitant increase in the proportion of central memory CD41 T cells (p 5 0.018) and naive CD4 1 T cells (p 5 0.04). These effects were not observed in the low-dose group.Conclusions: Cholecalciferol supplementation with 10,400 IU daily is safe and tolerable in patients with MS and exhibits in vivo pleiotropic immunomodulatory effects in MS, which include reduction of interleukin-17 production by CD41 T cells and decreased proportion of effector memory CD41 T cells with concomitant increase in central memory CD4 1 T cells and naive CD4 1 T cells. Classification of evidence:This study provides Class I evidence that cholecalciferol supplementation with 10,400 IU daily is safe and well-tolerated in patients with MS and exhibits in vivo pleiotropic immunomodulatory effects. 6,7 These observations may reflect the pleiotropic immunomodulatory effects of vitamin D, involving the innate and adaptive immune system. 7-9The majority of studies examining the immunologic effects of vitamin D have been conducted either in vitro or in animal models, and human studies have employed differing methods and produced discrepant results. [10][11][12] The immunologic effects of high-dose compared to lowdose vitamin D in patients with MS remain unclear. We also sought to confirm that cholecalciferol at 10,000 IU daily is well-tolerated in patients with MS.

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Section: High-dose Vitamin D Treatment Results In a Decrease In The Cmentioning

confidence: 99%

Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis

et al. 2016

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“…Ennek egyik magyarázata az lehet, hogy a Dvitamin immun modulátor hatású, jellemzői hasonlítanak a bétainter feronhoz [153]. A Dvitamin valódi terápiás hatására a betegség gyógyításában egy jelenleg is zajló vizsgálat (SOLAR) adhat választ [154].…”

Section: D-vitamin-hiány Hatása Az Idegrendszerre Dr Kovács Tiborunclassified

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et al. 2012

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A Dvitamin anyagcseréje egyedülálló az emberi szer vezetben. Hatása szerteágazó, szinte minden szervrend szerben érvényesül. Hiánya az egyik legnagyobb egész ségügyi probléma a civilizált világban. A probléma megoldása széles körű összefogást sürget. Ezt felis merve, a Dvitaminhiány következményeivel küzdő legnagyobb magyarországi orvostársaságok közös kon szenzust dolgoztak ki a Dvitaminhiány jelentőségéről, felismerési lehetőségeiről, a prevenció és a kezelés java solt módjairól. A társaságok szakmai irányelvei mellett ennek a konszenzusnak az eredménye iránymutatást ad a gyakorló orvosoknak a Dvitaminhiány megelőzésé hez és kezeléséhez. Emellett szeretné ráirányítani a szak mai döntéshozók és a laikus közönség fi gyelmét a prob léma fontosságára.

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“…children of MS patients) have not yet been evaluated. Larger randomized trials are ongoing and will hopefully provide further answers [4,5]. In the meantime, supplementation is well-tolerated, safe, at a low cost and should be prescribed in vitamin D-deficient patients.…”

mentioning

confidence: 99%

Vitamin D supplementation in multiple sclerosis patients in 2012: hype or reality as an adjunctive therapy?

Pesch

Sindic

2012

Acta Neurol Belg

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Efficacy of vitamin D3 as add-on therapy in patients with relapsing–remitting multiple sclerosis receiving subcutaneous interferon beta-1a: A Phase II, multicenter, double-blind, randomized, placebo-controlled trial

Cited by 108 publications

References 34 publications

Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis

Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis

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Vitamin D supplementation in multiple sclerosis patients in 2012: hype or reality as an adjunctive therapy?

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