Evidence map›Paper›PMID 31594857›Full record

Trial reportNeurology2019

Randomized trial of daily high-dose vitamin D

Raymond Hupperts, Joost Smolders, Reinhold Vieth, Trygve Holmøy, Kurt Marhardt, Myriam Schluep, Joep Killestein, Frederik Barkhof, Manolo Beelke, Luigi M E Grimaldi and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01285401 (A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif®), which is not on this map. Cited by 67 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 6 pooled it
9.8field-weighted citation impact, top 1% of its field
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.

NCT01285401 phase2completednot on this map

A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif®

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2011 to 2015Enrolled260ConditionsRelapsing-Remitting Multiple SclerosisArmsVigantOL oil plus interferon beta-1a (Rebif), Placebo plus interferon beta-1a (Rebif), Interferon beta-1a (Rebif®) alone
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 6 syntheses or guidelines pooled it, 127 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Vitamins DFrontiers in immunology · 2022
    Trial
  9. Trial
  10. Trial
  11. Review
  12. Insights from a trial of narrowband UVB for early multiple sclerosis.Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology · 2026
    Review
  13. Review
  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. Article
  17. Review
  18. Article
  19. Article
  20. Article

7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 6 countries.

Raymond HuppertsFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy. r.hupperts@zuyderland.nl.
Joost SmoldersFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy.ORCID 0000-0001-9766-8661
Reinhold ViethFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy.
Trygve HolmøyFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy.
Kurt MarhardtFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy.
Myriam SchluepFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy.
Joep KillesteinFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy.
Frederik BarkhofFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy.
Manolo BeelkeFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy.
Luigi M E GrimaldiFrom the Department of Neurology (R.H., J.S.,), Zuyderland Medical Centre Sittard, Maastricht University Medical Centre; Department of Neurology (J.S.), Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands; Department of Nutritional Sciences (R.V.), University of Toronto, Canada; Akershus University Hospital and University of Oslo (T.H.), Norway; Merck GmbH (K.M.), Vienna, Austria; Service de Neurologie (M.S.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Departments of Neurology (J.K.) and Radiology and Nuclear Medicine (F.B.), VU University Medical Centre, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Independent Consultant (M.B.), Krailling, Germany; and U.O.C. Neurologia and Multiple Sclerosis Center (L.M.E.G.), Fondazione Istituto G. Giglio di Cefalù, Italy.
SOLAR Study Group
Radboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIn 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

methodsEligible 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

resultsAt 48 weeks, 36.3% of patients who received high-dose vitamin D

conclusionsSOLAR did not establish a benefit for high-dose vitamin D 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.

Indexed as

Adjuvants, ImmunologicAdultBrainCholecalciferolDouble-Blind MethodDrug Therapy, CombinationFemaleHumansInterferon beta-1aMagnetic Resonance ImagingMaleMultiple Sclerosis, Relapsing-RemittingTreatment OutcomeVitamin DVitamins25-hydroxyvitamin DAdjuvants, ImmunologicCholecalciferolInterferon beta-1aVitamin DVitamins

Identifiers

PMID31594857
PMCPMC6946471
OpenAlexW2979333257

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.