Funded in part by Sanofi, Biogen, Teva Pharmaceutical Industries
Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE)
Camu W, Lehert P, Pierrot-Deseilligny C, Hautecoeur P, Besserve A, Jean Deleglise AS, Payet M, Thouvenot E, Souberbielle JC
Neurology(R) neuroimmunology & neuroinflammation · 76 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Industry funded
- Company
- Sanofi
- Company
- Biogen
- Company
- Teva Pharmaceutical Industries
- Authors
- At least one author declares a financial tie to industry
Based on 3 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2019-08-06 · Neurol Neuroimmunol Neuroinflamm · vol. 6 · issue 5
- Publisher
- Wolters Kluwer
- Cited
- 104 citations · more than 98% of similar papers · 7.3× the field average
- Impact
- Top 10% most cited in its field
- References
- 26 works
- Access
- Open access (journal) · CC-BY-NC-ND
- Research areas
- Multiple Sclerosis Research Studies · Rheumatoid Arthritis Research and Therapies · Systemic Sclerosis and Related Diseases
- Keywords
- Cholecalciferol, Tolerability, Medicine, Vitamin D and neurology, Placebo, Internal medicine, Gastroenterology, Adverse effect, Randomization, Clinical endpoint, Randomized controlled trial, Expanded Disability Status Scale, Multiple sclerosis, Pathology, Psychiatry
- MeSH
- humans, multiple sclerosis, relapsing-remitting, vitamin d deficiency, cholecalciferol, immunosuppressive agents, follow-up studies, double-blind method, adult, middle aged, female, male, interferon beta-1a
9 authors
From FR, AU, US, BE
- William CamuHôpital Necker-Enfants Malades; The University of Melbourne; Saint Vincent Health System; Institut de Génomique Fonctionnelle de Lyon; Groupe Hospitalier de l'Institut Catholique de Lille; UCLouvain
- Philippe LehertHôpital Necker-Enfants Malades; The University of Melbourne; Saint Vincent Health System; Institut de Génomique Fonctionnelle de Lyon; Groupe Hospitalier de l'Institut Catholique de Lille; UCLouvain
- Charles Pierrot‐DeseillignyHôpital Necker-Enfants Malades; The University of Melbourne; Saint Vincent Health System; Institut de Génomique Fonctionnelle de Lyon; Groupe Hospitalier de l'Institut Catholique de Lille; UCLouvain
- Patrick HautecœurHôpital Necker-Enfants Malades; The University of Melbourne; Saint Vincent Health System; Institut de Génomique Fonctionnelle de Lyon; Groupe Hospitalier de l'Institut Catholique de Lille; UCLouvain
- Anne BesserveHôpital Necker-Enfants Malades; The University of Melbourne; Saint Vincent Health System; Institut de Génomique Fonctionnelle de Lyon; Groupe Hospitalier de l'Institut Catholique de Lille; UCLouvain
- Anne-Sophie Jean DelegliseHôpital Necker-Enfants Malades; The University of Melbourne; Saint Vincent Health System; Institut de Génomique Fonctionnelle de Lyon; Groupe Hospitalier de l'Institut Catholique de Lille; UCLouvain
Abstract
Objective
To evaluate the safety and efficacy of cholecalciferol in patients with relapsing-remitting MS (RRMS).
Methods
In this double-blind, placebo-controlled parallel-group, 2-year study, 181 patients with RRMS were randomized 1:1. Key inclusion criteria were a low serum 25-hydroxy vitamin D (25OHD) concentration (<75 nmol/L), a treatment with interferon beta-1a 44 μg (SC 3 times per week) 4 months ± 2 months before randomization, and at least one documented relapse during the previous 2 years. Patients received high-dose oral cholecalciferol 100,000 IU or placebo every other week for 96 weeks. Primary outcome measure was the change in the annualized relapse rate (ARR) at 96 weeks. Secondary objectives included safety and tolerability of cholecalciferol and efficacy assessments (ARR, MRI parameters, and Expanded Disability Status Scale [EDSS]).
Results
The primary end point was not met. In patients who completed the 2-year follow-up (45 with cholecalciferol and 45 with placebo), all efficacy parameters favored cholecalciferol with an ARR reduction (p = 0.012), less new hypointense T1-weighted lesions (p = 0.025), a lower volume of hypointense T1-weighted lesions (p = 0.031), and a lower progression of EDSS (p = 0.026). The overall rate of adverse events was well balanced between groups.
Conclusions
Although the primary end point was not met, these data suggest a potential treatment effect of cholecalciferol in patients with RRMS already treated with interferon beta-1a and low serum 25OHD concentration. Together with the good safety profile, these data support the exploration of cholecalciferol treatment in such patients with RRMS.
Clinicaltrialsgov identifier
NCT01198132.
Classification of evidence
This study provides Class II evidence that for patients with RRMS and low serum 25OHD, cholecalciferol did not significantly affect ARRs.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).
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