Evidence map›Paper›PMID 31454777›Full record

Trial reportNeurology(R) neuroimmunology & neuroinflammation2019

Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE).

William Camu, Philippe Lehert, Charles Pierrot-Deseilligny, Patrick Hautecoeur, Anne Besserve, Anne-Sophie Jean Deleglise, Marianne Payet, Eric Thouvenot, Jean Claude Souberbielle

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology(R) neuroimmunology & neuroinflammation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01198132 (A Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol), which is not on this map. Cited by 57 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 8 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01198132 phase2completednot on this map

A Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol (Vitamin D3) in Patients With Relapsing- Multiple Sclerosis (RMS) Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2009 to 2015Enrolled129ConditionsMultiple SclerosisArmsCholecalciferol (Vitamin D3), Placebo, Rebif
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Vitamins DFrontiers in immunology · 2022
    Trial
  10. Trial
  11. Trial
  12. Review
  13. Article
  14. The Role of Vitamin D in Autoimmune Diseases.International journal of molecular sciences · 2026
    Review
  15. Vitamin D and Brain Health.Advances in experimental medicine and biology · 2026
    Review
  16. Observational
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

William CamuFrom CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France. w-camu@chu-montpellier.fr.
Philippe LehertFrom CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.
Charles Pierrot-DeseillignyFrom CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.
Patrick HautecoeurFrom CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.
Anne BesserveFrom CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.
Anne-Sophie Jean DelegliseFrom CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.
Marianne PayetFrom CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.
Eric ThouvenotFrom CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.ORCID 0000-0001-8671-7747
Jean Claude SouberbielleFrom CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and efficacy of cholecalciferol in patients with relapsing-remitting MS (RRMS).

methodsIn 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]).

resultsThe 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 (

conclusionsAlthough 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.

Indexed as

AdultCholecalciferolDouble-Blind MethodFemaleFollow-Up StudiesHumansImmunosuppressive AgentsInterferon beta-1aMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingVitamin D DeficiencyCholecalciferolImmunosuppressive AgentsInterferon beta-1a

Identifiers

PMID31454777
PMCPMC6705622

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.