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November 12, 2019; 93 (20) Null HypothesisOpen Access

Randomized trial of daily high-dose vitamin D3 in patients with RRMS receiving subcutaneous interferon β-1a

Raymond Hupperts, Joost Smolders, Reinhold Vieth, Trygve Holmøy, Kurt Marhardt, Myriam Schluep, Joep Killestein, Frederik Barkhof, Manolo Beelke, Luigi M.E. Grimaldi, on behalf of the SOLAR Study Group
First published October 8, 2019, DOI: https://doi.org/10.1212/WNL.0000000000008445
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Article Information

vol. 93 no. 20 e1906-e1916
DOI: 
https://doi.org/10.1212/WNL.0000000000008445
PubMed: 
31594857
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received August 22, 2018
  • Accepted in final form June 3, 2019
  • First Published October 8, 2019.

Article Versions

Copyright & Usage: 
Copyright © 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), 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.

Author Disclosures

    1. Raymond Hupperts, PhD*,
    2. Joost Smolders, MD, PhD*,
    3. Reinhold Vieth, PhD,
    4. Trygve Holmøy, PhD,
    5. Kurt Marhardt, MD,
    6. Myriam Schluep, MD,
    7. Joep Killestein, PhD,
    8. Frederik Barkhof, MD,
    9. Manolo Beelke, MD, PhD‡,
    10. Luigi M.E. Grimaldi, MD‡;
    11. on behalf of the SOLAR Study Group
  1. Raymond Hupperts, PhD*,
    2. Scientific Advisory Boards:

    1. I have received honoraria for scientific Advisory boards from: Biogen-Idec, Novartis, TEVA, Merck, Genzyme-Sanofi.

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. I have received Speaker's honoraria from; Biogen Idec,TEVA ,Genzyme-Sanofi and MERCK.

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. I have received PhD financial support from Biogen-Idec and Merck.

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  2. Joost Smolders, MD, PhD*,
    3. Scientific Advisory Boards:

    1. (1) Merck, steering committee

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. (1) Merck, speaker honorarium; (2) Novartis, speaker honorarium; (3) Sanofi Genzyme, speaker honorarium, (4) Biogen, speaker honorarium, (5) ECTRIMS, travel grant; (6) Swiss MS Society, travel grant, (7) Dutch Society for Immunology, travel grant, (8) European Charcot Foundation, travel grant, (9) At the Limits MS, travel grant, (10) RIMS, travel grant.

    Editorial Boards:

    1. (1) Frontiers in Immunology/ Neurology, review editor, 2017- present

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other activities:

    1. (1) Biogen, honorarium for development educational program in neuroimmunology

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) Nationaal MS Fonds, grant OZ2016-001, (2) Nationaal MS Fonds, grant OZ2018-003

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. Reinhold Vieth, PhD,
    4. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. Patent related to vitamin D administration

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License fee payments, Technology or Inventions:

    1. Infant Vitamin D method, patent royalty. Stock/Stock Options, Medical Equipment & Materials: Ddrops Company

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  4. Trygve Holmøy, PhD,
    5. Scientific Advisory Boards:

    1. 1) Commercial: Biogen2) Commercial: Sanofi3) Commercial: Roche4) Non profit: Norwegian Multiple Sclerosis Society

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. 1) Commercial: Speakers honoraria from Merck Serono2) Commercial: Speakers honoraria from Sanofi Aventis3) Commercial: Speakers honoraria from Biogen Idec4) Commercial: Speakers honoraria from Novartis5) Commercial: Speakers honoraria from Genzyme

    Editorial Boards:

    1. 1) Journal of the Norwegian Medical Association, Editorial Advisory Board member, 2008-present.2) The Open Virology Journal, Editorial Advisory Board member, 2010-present3) Future Neurology, Editorial Advisory Board member, 2010-present

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Merck Serono, Norway

    Research Support, Government Entities:

    1. 1) South East Health Authority Norway. Grant no 2017029, Project leader, 2018-20202) South East Health Authority Norway. Grant no 2016079, Project leader, 2017-20193) Norwegian Research Council. grant no 250864, Project leader, 2016-2020

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. ALS Norway

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  5. Kurt Marhardt, MD,
    6. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. (1)Merck Serono Central Europe, Regional Medical Manager, 2008-2009;(2)Merck Serono S.A. Geneva, Medical Affairs Director Neurology, 2010-2012;(3)Merck Serono, Director Business Unit Medical Affairs Neurology, 2012-2014; (4) Merck, Director Global Medical Affairs Neurology & Immunology, 2014-present

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  6. Myriam Schluep, MD,
    7. Scientific Advisory Boards:

    1. I have served on a scientific advisory board for (1) Biogen, (2) Genzyme, (3) Merck, (4) Novartis, and (5) Sanofi-Aventis.

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. I have received travel funding and/or speaker honoraria from (1) Biogen, (2) Genzyme, (3) Merck, (4) Novartis and (5) Sanofi-Aventis.

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. I have consulted for (1) Biogen, (2) Merck, (3) Novartis, (4) Genzyme, (5) Roche and (6) Sanofi-Aventis.

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. I have received research support from (1) Merck, (2) Novartis and (3) Biogen.

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  7. Joep Killestein, PhD,
    8. Scientific Advisory Boards:

    1. Consultancy (advisory boards) Novartis, Merck, Biogen, Genzyme, TEVA, Roche

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Speaker honoraria Biogen, Novartis, TEVA, Merck, Roche

    Editorial Boards:

    1. Editor of the official scientific journal of the Dutch Society of Neurology, the Dutch Society of Neurosurgeons and the Society of Flemish Neurologists (Tijdschrift voor Neurologie en Neurochirurgie). Editorial board MS Journal Editorial board Neurology

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Consultancy Novartis, Merck, Biogen, Genzyme, TEVA

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. I have been involved in clinical trials (including steering committees) of companies that market drugs for MS (Schering AG, Biogen Idec, Merck-Serono, Teva, Genzyme, Novartis and Roche).

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  8. Frederik Barkhof, MD,
    9. Scientific Advisory Boards:

    1. Scientific consultant to Bayer, Novartis, Biogen, Merck, Roche, Janssen, TEVA, Genzyme, IXICO, Apitope, GeNeuro

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. Editorial board member for Brain, Multiple Sclerosis Journal, Neuroradiology, Radiology, Neurology

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Consultant for Synthon, Janssen, Novartis, Biogen, Roche, TEVA, Merck, Apitope

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. EuroPOND co-PI (H2020), AMYPAD coordinator (IMI), NIHR- UCLH biomedical research centre

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Dutch foundation for MS Research - centre grant 2015-2018

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  9. Manolo Beelke, MD, PhD‡,
    10. Scientific Advisory Boards:

    1. I was member of the SOLAR steering committee organized by Merck Serono and chairman of the scientific advisory board for a phase 2 study in CIDP, organized by argenx.

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. The invention is directed towards a method of treating a subject suffering from multiple sclerosis wherein Vitamin D or an analogue thereof is administered on top of Interferon-beta.

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. (1) Merck Serono S.A. – Geneva, Switzerland, a branch of Merck Serono S.A., Coinsins, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany, Medical Director Neurology, Head of PoC Strategy Liaison Unit Neurology, Director Medical Affairs Neurodegenerative Diseases and Trial Director of the SOLAR study (High dose Vitamin D add-on to interferon beta-1a), 2006-2012 (2) Worldwide Clinical Trials, Trial Director of the SOLAR study (High dose Vitamin D add-on to interferon beta-1a), 2012-2017 (3) Manolo Beelke & Partners, Independent Consultant, since 2017

    Consultancies:

    1. (1) Navitas Lifesciences Inc (2) Argenx BVBA (3) Bionorica GmbH (4) BioEq GmbH (5) Wille Finance GmbH (6) Worldwide Clinical Trials INC (7) Acousia (8) Angelini (9) ESN Life Sciences (10) GREAT Network (11) Immunig GmbH (12) University of Modena (13) Verum GmbH (14)PJSZ Pharmasyntheyz

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1) Merck Serono (2) Worldwide Clinical Trials

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  10. Luigi M.E. Grimaldi, MD‡;
    11. Scientific Advisory Boards:

    1. Merck-Serono

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Biogen, Merck-Serono, Novartis, Sanofi-Aventis, TEVA, Roche

    Editorial Boards:

    1. Multiple Sclerosis and Demyelinating Disorders (BMC publisher), Editor-in-Chief, 2015-present

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. GLG, Biogen

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Merck-Serono, Biogen

    Research Support, Government Entities:

    1. Regione Siciliana, PSN 2016, P.I.

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  11. on behalf of the SOLAR Study Group
  1. From 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.
  1. Correspondence
    Dr. Hupperts r.hupperts{at}zuyderland.nl
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