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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: colecalciferol

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 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo capsules; Identically appearing placebo capsules not containing colecalciferol	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 Names: (Dekristol®, Swiss-Caps, Switzerland)
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	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 Names: (Dekristol®, Swiss-Caps, Switzerland)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of add-on -treatment with colecalciferol of MS patients treated with interferon beta-1b and	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	one year
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		12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	12 Months

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: August 16, 2011
• First Submitted That Met QC Criteria: September 12, 2011
• First Posted (Estimate): September 13, 2011

Study Record Updates

• Last Update Posted (Estimate): September 13, 2011
• Last Update Submitted That Met QC Criteria: September 12, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: MS; vitamin D; environment
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: EudraCT 2007-001958-99