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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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 (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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turku
• Collaborator: Bayer
• Treatments: Cholecalciferol; Interferon beta-1b; Interferon-beta; Interferons; Vitamin D; Vitamins

Criteria

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