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

NCT01339676 | Unknown Phase 4

• 2 other identifiers: 2007-001958-99EudraCT 2007-001958-99
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (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

  one year

Secondary Outcomes (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

  one year

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

Identically appearing once weekly peroral capsules

Drug: Placebo capsules

Interventions

Colecalciferol DRUG

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

Also known as: Vitamin D

1

Placebo capsules DRUG

Identically appearing once weekly peroral placebo capsules

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Turku University Hospital

Turku, FIN-20521, Finland

Location

Related Publications (1)

• 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.

  PMID: 22362918 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 21, 2011
• Study Start: March 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 19, 2011

Record last verified: 2011-04

Locations

FI (1)