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

Phase 4

• Conditions: Multiple Sclerosis
• Interventions: Drug: Placebo capsules; Drug: Colecalciferol

• Registration Number: NCT01339676
• Lead Sponsor: University of Turku

Brief Summary

This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4 pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Status Verified: 2011-04
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-21
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• age 18 to 55 years
• remitting-relapsing multiple sclerosis according to McDonald criteria who fulfill the reimbursement criteria for interferon-beta and have used interferon-beta-1b for at least one month
• EDSS (expanded disability statsu scale) ≤ 5
• no neutralising antibodies to INFB as measured by indirect MxA test
• prepared and considered to follow the protocol
• using appropriate contraceptive methods (women of childbearing potential)
• has given informed consent

Exclusion Criteria

• serum calcium >2.6 mmol/L
• serum 25(OH)D2 (kalsidiol) > 85 nmol/L
• presence of primary hyperparathyroidism (serum intact PTH, parathyroid hormone)>65 ng/L)
• pregnancy or unwillingness to use contraception
• alcohol or drug abuse
• use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses
• current use of other immunomodulatory therapy than interferon-beta-1b
• known allergy to cholecalciferol or arachis oil (peanuts)
• therapy with digitalis, calcitonin or active vitamin D3 analogues during the previous 12 months or multivitamins containing vitamin D during previous two weeks preceding study entry
• any condition predisposing to hypercalcaemia (such as any type of cancer)
• sarcoidosis
• nephrolithiasis or renal insufficiency, serum creatinine above 1.5 times the normal upper reference limit
• significant hypertension (Blood Pressure <180/110 mmHg)
• hyperthyroidism, or hypothyroidism in the year before the study began
• a history of nephrolithiasis during the previous five years
• cardiac insufficiency or significant cardiac dysrhythmia
• unstable or advanced ischaemic heart disease
• has suffered a major depression

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo capsules	Identically appearing once weekly peroral capsules
1	Colecalciferol	Once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D

Primary Outcome Measures

Name	Time	Method
Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months	one year

Secondary Outcome Measures

Name	Time	Method
Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on Measure: T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation	one year

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland