A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly (CHOLINE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01198132 |
Recruitment Status :
Completed
First Posted : September 9, 2010
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
|
Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborator:
Merck Serono S.A.S, France
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | September 8, 2010 | |||
First Posted Date ICMJE | September 9, 2010 | |||
Results First Submitted Date ICMJE | December 6, 2016 | |||
Results First Posted Date ICMJE | December 14, 2017 | |||
Last Update Posted Date | December 14, 2017 | |||
Actual Study Start Date ICMJE | November 2009 | |||
Actual Primary Completion Date | March 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Annualized Relapse Rate [ Time Frame: 2 years post treatment (IMP) administration ] The annualized relapse rate was calculated for each treatment group as follows: the number of relapses observed during the study period divided by the time spent in the study (in years).
|
|||
Original Primary Outcome Measures ICMJE |
Reduction in rate of relapse [ Time Frame: After 2 years of treatment ] Relapse rate is expressed as percentage difference between the two groups
|
|||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly | |||
Official Title ICMJE | 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 | |||
Brief Summary | The aim of this multicentre, randomised, double-blind, placebo-controlled study is to evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin D3) in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.) interferon beta-1a 44 microgram (mcg) [Rebif] 3 times weekly. The subjects will be divided into 2 groups, one receiving cholecalciferol 100,000 IU twice monthly along with Rebif treatment and the other group will be on placebo along with Rebif treatment. A total of 200 subjects will be recruited in 20-30 centres in France. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Supportive Care |
|||
Condition ICMJE | Multiple Sclerosis | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * | Camu W, Lehert P, Pierrot-Deseilligny C, Hautecoeur P, Besserve A, Jean Deleglise AS, Payet M, Thouvenot E, Souberbielle JC. Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE). Neurol Neuroimmunol Neuroinflamm. 2019 Aug 6;6(5). pii: e597. doi: 10.1212/NXI.0000000000000597. Print 2019 Sep. Erratum in: Neurol Neuroimmunol Neuroinflamm. 2019 Nov 15;7(1):. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
129 | |||
Original Estimated Enrollment ICMJE |
250 | |||
Actual Study Completion Date ICMJE | November 2015 | |||
Actual Primary Completion Date | March 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01198132 | |||
Other Study ID Numbers ICMJE | 701068-524 2009-013695-46 ( EudraCT Number ) |
|||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Merck KGaA, Darmstadt, Germany | |||
Study Sponsor ICMJE | Merck KGaA, Darmstadt, Germany | |||
Collaborators ICMJE | Merck Serono S.A.S, France | |||
Investigators ICMJE |
|
|||
PRS Account | Merck KGaA, Darmstadt, Germany | |||
Verification Date | May 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |