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

• ClinicalTrials.gov Identifier: NCT01339676
• Recruitment Status: Unknown
• First Posted: April 21, 2011
• Last Update Posted: May 19, 2011
• Sponsor: University of Turku
• Information provided by: University of Turku

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Drug: Colecalciferol; Drug: Placebo capsules	Phase 4

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: Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
• Study Start Date: March 2008
• Estimated Primary Completion Date: May 2011
• Estimated Study Completion Date: June 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 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	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; Other Name: Vitamin D
Placebo Comparator: 2; Identically appearing once weekly peroral capsules	Drug: Placebo capsules; Identically appearing once weekly peroral placebo capsules

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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 [ Time Frame: one year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Finland

Turku University Hospital

Turku, Finland, FIN-20521

Sponsors and Collaborators

University of Turku

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Soilu-Hanninen M, Aivo J, Lindstrom BM, Elovaara I, Sumelahti ML, Farkkila M, Tienari P, Atula S, Sarasoja T, Herrala L, Keskinarkaus I, Kruger J, Kallio T, Rocca MA, Filippi M. A randomised, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon beta-1b in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2012 May;83(5):565-71. doi: 10.1136/jnnp-2011-301876. Epub 2012 Feb 22.

• Responsible Party: Merja Soilu-Hanninen, MD, PhD, docent, neurologist, University of Turku, Department of Neurology, Turku, Finland
• ClinicalTrials.gov Identifier: NCT01339676
• Other Study ID Numbers: 2007-001958-99; EudraCT 2007-001958-99
• First Posted: April 21, 2011
• Last Update Posted: May 19, 2011
• Last Verified: April 2011

Keywords provided by University of Turku:

Vitamin D; Multiple Sclerosis; MRI; Randomised Trial; Finland

Additional relevant MeSH terms:

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