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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)

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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:
Collaborator:
Merck Serono S.A.S, France
Information provided by (Responsible Party):
Merck KGaA

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition: Multiple Sclerosis
Interventions: Dietary Supplement: Cholecalciferol (Vitamin D3)
Dietary Supplement: Placebo
Drug: Rebif

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 129 subjects were randomized. Out of which 126 subjects treated in the study and 90 subjects completed the study.

Reporting Groups
  Description
Cholecalciferol Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
Placebo Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.

Participant Flow:   Overall Study
    Cholecalciferol   Placebo
STARTED   63   66 
COMPLETED   45   45 
NOT COMPLETED   18   21 
Withdrawal by Subject                4                5 
Physician Decision                5                4 
Other Unspecified                3                6 
Lack of Efficacy                2                3 
Sign/symptoms of underlying disease                2                1 
Abnormal/clinically significant biologic                1                1 
Adverse Event                0                1 
Protocol Violation                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) set included all randomized subjects.

Reporting Groups
  Description
Cholecalciferol Subjects received Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
Placebo Subjects received matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
Total Total of all reporting groups

Baseline Measures
   Cholecalciferol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   66   129 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.5  (9.29)   36.9  (8.34)   37.7  (8.81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      50  79.4%      39  59.1%      89  69.0% 
Male      13  20.6%      27  40.9%      40  31.0% 


  Outcome Measures

1.  Primary:   Annualized Relapse Rate   [ Time Frame: 2 years post treatment (IMP) administration ]

2.  Secondary:   Time to First Documented Relapse   [ Time Frame: 2 years post treatment (IMP) administration ]

3.  Secondary:   Mean Number of Relapses Per Subject   [ Time Frame: 2 years post treatment (IMP) administration ]

4.  Secondary:   Number of Relapse-Free (Documented) Subjects   [ Time Frame: 2 years post treatment (IMP) administration ]

5.  Secondary:   Cumulative Probability of Progression of Disability (Kaplan-Meier Curves)   [ Time Frame: Baseline up to week 96 ]

6.  Secondary:   Number of New or Extended Lesions by T1- and T2-Weighted Magnetic Resonance Imaging (MRI)   [ Time Frame: 2 years post treatment (IMP) administration ]

7.  Secondary:   Changes From Baseline in Measured Lesion Load (T2)   [ Time Frame: Baseline, Week 96 ]

8.  Secondary:   Change From Baseline in Measurement and Evaluation of Cognitive Ability by Paced Auditory Serial Addition Task (PASAT) Total Score At Week 96   [ Time Frame: Baseline, Week 96 ]

9.  Secondary:   Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L)   [ Time Frame: 2 years post treatment (IMP) administration ]

10.  Secondary:   Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Abnormal Clinical Laboratory   [ Time Frame: Baseline up to end of treatment (week 96) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Title: Merck KGaA Communication Center
Organization: Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com



Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01198132     History of Changes
Other Study ID Numbers: 701068-524
2009-013695-46 ( EudraCT Number )
First Submitted: September 8, 2010
First Posted: September 9, 2010
Results First Submitted: December 6, 2016
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017