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

• ClinicalTrials.gov Identifier: NCT01432704
• Recruitment Status: Completed
• First Posted: September 13, 2011
• Last Update Posted: September 13, 2011
• Sponsor: University of Turku
• Collaborator: Bayer
• Information provided by (Responsible Party): Merja Soilu-Hänninen, University of Turku

Study Description

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 (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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Drug: colecalciferol	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
• Study Start Date: March 2008
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Merja Soilu-Hänninen, MD, PhD, neurologist, University of Turku
• ClinicalTrials.gov Identifier: NCT01432704
• Other Study ID Numbers: EudraCT 2007-001958-99
• First Posted: September 13, 2011
• Last Update Posted: September 13, 2011
• Last Verified: September 2011

Keywords provided by Merja Soilu-Hänninen, University of Turku:

MS; vitamin D; environment

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Cholecalciferol; Vitamin D; Vitamins; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents