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

• Status: Unknown status
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turku
• Treatments: Cholecalciferol; Ergocalciferols; Interferon beta-1b; Interferon-beta; Interferons; Vitamin D; Vitamins

Criteria

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