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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01339676
• Other study ID #: 2007-001958-99
• Secondary ID: EudraCT 2007-001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 19, 2011
• Last updated: May 18, 2011
• Start date: March 2008
• Est. completion date: June 2011

Study information

• Verified date: April 2011
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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
• Placebo capsules
Identically appearing once weekly peroral placebo capsules

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No