Cargando…
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...
Autores principales: | , , , , , , , , , |
---|---|
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 |
_version_ | 1783485369780535296 |
---|---|
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. |
format | Online Article Text |
id | pubmed-6946471 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT huppertsraymond randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT smoldersjoost randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT viethreinhold randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT holmøytrygve randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT marhardtkurt randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT schluepmyriam randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT killesteinjoep randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT barkhoffrederik randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT beelkemanolo randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT grimaldiluigime randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a AT randomizedtrialofdailyhighdosevitamind3inpatientswithrrmsreceivingsubcutaneousinterferonb1a |