Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS) (100207MS-H)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Merja Soilu-Hänninen, University of Turku
ClinicalTrials.gov Identifier:
NCT01432704
First received: August 16, 2011
Last updated: September 12, 2011
Last verified: September 2011

August 16, 2011
September 12, 2011
March 2008
May 2011   (final data collection date for primary outcome measure)
  • To evaluate the safety and tolerability of add-on -treatment with colecalciferol of MS patients treated with interferon beta-1b and [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
  • To estimate the effect of interferon-beta-1b with an add-on of colecalciferol versus interferon-beta-1b with an add-on of placebo on MRI T2 BOD at 12 months in comparison with MRI T2 BOD at baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01432704 on ClinicalTrials.gov Archive Site
Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)
Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS

This is a one-year multi-centre, double blind, placebo controlled, randomized trial investigating oral vitamin D3 (Colecalciferol) as an add-on treatment to interferon-beta-1b for Multiple Sclerosis (MS). Not less than one month after initiation of therapy with interferon beta 1b, MS patients will be randomised to once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 0.5 mg of vitamin D3, or to once weekly peroral treatment with matching placebo. The hypothesis is that vitamin D suppresses clinical and MRI activity of MS.

The patients will be examined clinically at baseline and at 6, and 12 months. Laboratory assessments will be performed at screening and 1, 2, 3, 6, 9 and 12 months after baseline. MRI will be performed (T1-weighted and T2-weighted) at randomization and 12 months thereafter. Sample size is 80 patients: two groups with 40 patients in each group. The primary statistical analyses will be based on the intent-to-treat (ITT) population which consist of all randomized patients who have started study medication. The primary efficacy variable MRI T2 BOD will be analyzed using ANCOVA with MRI T2 BOD at baseline as covariate. The incidence (with corresponding 95% confidence interval) of hypercalcaemia (mild, moderate and severe), laboratory abnormalities, dose adjustments, and significant adverse events will be calculated. The vitamin D status (proportion of patients with P-PTH <20 ng/l and S-OH(D)2 >85 nmol/l) at 6 and 12 months will be analyzed using logistic regression.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
Drug: colecalciferol
Once weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) that contain 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months
Other Name: (Dekristol®, Swiss-Caps, Switzerland)
  • Placebo Comparator: placebo capsules
    Identically appearing placebo capsules not containing colecalciferol
    Intervention: Drug: colecalciferol
  • Active Comparator: colecalciferol capsules
    Once weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months
    Intervention: Drug: colecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
August 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • RRMS EDSS 0-5
  • Betaferon used for at lest one month with positive MxA-response

Exclusion Criteria:

  • hypercalcaemia
  • kidney stones
  • uncontrolled hypertension
  • hypothyreosis
  • peanut allergy
  • severe depression
  • sarcoidosis
  • use of other IMD than interferon-beta
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01432704
EudraCT 2007-001958-99
Not Provided
Merja Soilu-Hänninen, University of Turku
University of Turku
Bayer
Not Provided
University of Turku
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP