Financiado en parte por Sanofi, Biogen, Teva Pharmaceutical Industries, Merck KGaA
Randomized trial of daily high-dose vitamin D<sub>3</sub> in patients with RRMS receiving subcutaneous interferon β-1a
Hupperts R, Smolders J, Vieth R, Holmøy T, Marhardt K, Schluep M, Killestein J, Barkhof F, Beelke M, Grimaldi LME, SOLAR Study Group
Neurology · 105 citas
Etiquetas de revisión
Vínculos de autores con la industriaFinanciado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Sanofi
- Empresa
- Biogen
- Empresa
- Teva Pharmaceutical Industries
- Empresa
- Merck KGaA
- Gobierno
- National Institute for Health and Care Research
- Gobierno
- Norges Forskningsråd
- Universidad u hospital
- University College London Hospitals NHS Foundation Trust
- Autores
- Al menos un autor declara un vínculo económico con la industria
Según 7 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2019-10-08 · Neurology · vol. 93 · número 20 · págs. e1906–e1916
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 134 citas · más que el 99% de estudios similares · 10.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 30 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC-ND
- Áreas de investigación
- Multiple Sclerosis Research Studies · Vitamin D Research Studies · Psoriasis: Treatment and Pathogenesis
- Palabras clave
- relapsing-remitting multiple sclerosis, vitamin D3 supplementation, interferon beta-1a, subcutaneous interferon therapy, no evidence of disease activity, MRI lesion volume, T2 lesions, disease-modifying therapy, adjunctive therapy, vitamin D deficiency, safety and tolerability, vitamin D toxicity, vitamin D receptor agonists
- MeSH
- brain, humans, multiple sclerosis, relapsing-remitting, cholecalciferol, vitamins, vitamin d, adjuvants, immunologic, magnetic resonance imaging, treatment outcome, drug therapy, combination, double-blind method, adult, female, male, interferon beta-1a
11 autores
- Raymond Hupperts🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Joost Smolders🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Reinhold Vieth🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Trygve Holmøy🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Kurt Marhardt🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Myriam Schluep🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Joep Killestein🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Frederik Barkhof🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Manolo Beelke🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Luigi M. E. Grimaldi🇦🇹🇳🇴🇨🇦🇳🇱🇨🇭🇬🇧University of Vienna; University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Centre Hospitalier Universitaire Vaudois; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum; University College London; Amsterdam UMC Location Vrije Universiteit Amsterdam
- on behalf of the SOLAR Study Group🇳🇴🇨🇦🇳🇱University of Oslo; University of Toronto; Maastricht University Medical Centre; Akershus University Hospital; Canisius-Wilhelmina Ziekenhuis; Zuyderland Medisch Centrum
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 D3 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 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 D3 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 D3 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 D3 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.
Clinicaltrialsgov 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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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