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Randomized trial of daily high-dose vitamin D(3) in patients with RRMS receiving subcutaneous interferon β-1a

OBJECTIVE: In the phase II, randomized, double-blind, placebo-controlled Supplementation of Vigantol Oil versus Placebo Add-on in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Receiving Rebif Treatment (SOLAR) study (NCT01285401), we assessed the efficacy and safety of add-on vitamin D...

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Autores principales: Hupperts, Raymond, Smolders, Joost, Vieth, Reinhold, Holmøy, Trygve, Marhardt, Kurt, Schluep, Myriam, Killestein, Joep, Barkhof, Frederik, Beelke, Manolo, Grimaldi, Luigi M.E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6946471/
https://www.ncbi.nlm.nih.gov/pubmed/31594857
http://dx.doi.org/10.1212/WNL.0000000000008445
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author Hupperts, Raymond
Smolders, Joost
Vieth, Reinhold
Holmøy, Trygve
Marhardt, Kurt
Schluep, Myriam
Killestein, Joep
Barkhof, Frederik
Beelke, Manolo
Grimaldi, Luigi M.E.
author_facet Hupperts, Raymond
Smolders, Joost
Vieth, Reinhold
Holmøy, Trygve
Marhardt, Kurt
Schluep, Myriam
Killestein, Joep
Barkhof, Frederik
Beelke, Manolo
Grimaldi, Luigi M.E.
author_sort Hupperts, Raymond
collection PubMed
description OBJECTIVE: In the phase II, randomized, double-blind, placebo-controlled Supplementation of Vigantol Oil versus Placebo Add-on in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Receiving Rebif Treatment (SOLAR) study (NCT01285401), we assessed the efficacy and safety of add-on vitamin D(3) in patients with RRMS. METHODS: Eligible patients with RRMS treated with SC interferon-β-1a (IFN-β-1a) 44 μg 3 times weekly and serum 25(OH)D levels <150 nmol/L were included. From February 15, 2011, to May 11, 2015, 229 patients were included and randomized 1:1 to receive SC IFN-β-1a plus placebo (n = 116) or SC IFN-β-1a plus oral high-dose vitamin D(3) 14,007 IU/d (n = 113). The revised primary outcome was the proportion of patients with no evidence of disease activity (NEDA-3) at week 48. RESULTS: At 48 weeks, 36.3% of patients who received high-dose vitamin D(3) had NEDA-3, without a statistically significant difference in NEDA-3 status between groups (placebo 35.3%; odds ratio 0.93; 95% confidence interval [CI] 0.53–1.63; p = 0.80). Compared with placebo, the high-dose vitamin D(3) group had better MRI outcomes for combined unique active lesions (incidence rate ratio 0.68; 95% CI 0.52–0.89; p = 0.0045) and change from baseline in total volume of T2 lesions (difference in mean ranks: −0.074; p = 0.035). CONCLUSIONS: SOLAR did not establish a benefit for high-dose vitamin D(3) as add-on to IFN-β-1a, based on the primary outcome of NEDA-3, but findings from exploratory outcomes suggest protective effects on development of new MRI lesions in patients with RRMS. CLINICALTRIALS.GOV IDENTIFIER: NCT01285401. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS treated with SC IFN-β-1a, 48 weeks of cholecalciferol supplementation did not promote NEDA-3 status.
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spelling pubmed-69464712020-02-10 Randomized trial of daily high-dose vitamin D(3) in patients with RRMS receiving subcutaneous interferon β-1a Hupperts, Raymond Smolders, Joost Vieth, Reinhold Holmøy, Trygve Marhardt, Kurt Schluep, Myriam Killestein, Joep Barkhof, Frederik Beelke, Manolo Grimaldi, Luigi M.E. Neurology Article OBJECTIVE: In the phase II, randomized, double-blind, placebo-controlled Supplementation of Vigantol Oil versus Placebo Add-on in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Receiving Rebif Treatment (SOLAR) study (NCT01285401), we assessed the efficacy and safety of add-on vitamin D(3) in patients with RRMS. METHODS: Eligible patients with RRMS treated with SC interferon-β-1a (IFN-β-1a) 44 μg 3 times weekly and serum 25(OH)D levels <150 nmol/L were included. From February 15, 2011, to May 11, 2015, 229 patients were included and randomized 1:1 to receive SC IFN-β-1a plus placebo (n = 116) or SC IFN-β-1a plus oral high-dose vitamin D(3) 14,007 IU/d (n = 113). The revised primary outcome was the proportion of patients with no evidence of disease activity (NEDA-3) at week 48. RESULTS: At 48 weeks, 36.3% of patients who received high-dose vitamin D(3) had NEDA-3, without a statistically significant difference in NEDA-3 status between groups (placebo 35.3%; odds ratio 0.93; 95% confidence interval [CI] 0.53–1.63; p = 0.80). Compared with placebo, the high-dose vitamin D(3) group had better MRI outcomes for combined unique active lesions (incidence rate ratio 0.68; 95% CI 0.52–0.89; p = 0.0045) and change from baseline in total volume of T2 lesions (difference in mean ranks: −0.074; p = 0.035). CONCLUSIONS: SOLAR did not establish a benefit for high-dose vitamin D(3) as add-on to IFN-β-1a, based on the primary outcome of NEDA-3, but findings from exploratory outcomes suggest protective effects on development of new MRI lesions in patients with RRMS. CLINICALTRIALS.GOV IDENTIFIER: NCT01285401. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS treated with SC IFN-β-1a, 48 weeks of cholecalciferol supplementation did not promote NEDA-3 status. Lippincott Williams & Wilkins 2019-11-12 /pmc/articles/PMC6946471/ /pubmed/31594857 http://dx.doi.org/10.1212/WNL.0000000000008445 Text en Copyright © 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Article
Hupperts, Raymond
Smolders, Joost
Vieth, Reinhold
Holmøy, Trygve
Marhardt, Kurt
Schluep, Myriam
Killestein, Joep
Barkhof, Frederik
Beelke, Manolo
Grimaldi, Luigi M.E.
Randomized trial of daily high-dose vitamin D(3) in patients with RRMS receiving subcutaneous interferon β-1a
title Randomized trial of daily high-dose vitamin D(3) in patients with RRMS receiving subcutaneous interferon β-1a
title_full Randomized trial of daily high-dose vitamin D(3) in patients with RRMS receiving subcutaneous interferon β-1a
title_fullStr Randomized trial of daily high-dose vitamin D(3) in patients with RRMS receiving subcutaneous interferon β-1a
title_full_unstemmed Randomized trial of daily high-dose vitamin D(3) in patients with RRMS receiving subcutaneous interferon β-1a
title_short Randomized trial of daily high-dose vitamin D(3) in patients with RRMS receiving subcutaneous interferon β-1a
title_sort randomized trial of daily high-dose vitamin d(3) in patients with rrms receiving subcutaneous interferon β-1a
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6946471/
https://www.ncbi.nlm.nih.gov/pubmed/31594857
http://dx.doi.org/10.1212/WNL.0000000000008445
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