Status:
COMPLETED
Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)
Lead Sponsor:
University of Turku
Collaborating Sponsors:
Bayer
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
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 (...
Detailed Description
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 performe...
Eligibility Criteria
Inclusion
- RRMS EDSS 0-5
- Betaferon used for at lest one month with positive MxA-response
Exclusion
- hypercalcaemia
- kidney stones
- uncontrolled hypertension
- hypothyreosis
- peanut allergy
- severe depression
- sarcoidosis
- use of other IMD than interferon-beta
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01432704
Start Date
March 1 2008
End Date
August 1 2011
Last Update
September 13 2011
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