Skip to main content
OpenTrials
Completed

NCT Number: NCT01432704

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colecalciferol

Drug

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 names: (Dekristol®, Swiss-Caps, Switzerland)

Primary outcomes

  1. 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

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Bayer

Registry information

Official study title

Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS

Acronym: 100207MS-H

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 13, 2011
Registry last updated
Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.