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

NCT01432704 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2011-09-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • University of Turku

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-05-31
Completion
2011-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432704 on ClinicalTrials.gov