Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Turku.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Turku
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT01339676
First received: April 19, 2011
Last updated: May 18, 2011
Last verified: April 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Colecalciferol Drug: Placebo capsules |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS |
Resource links provided by NLM:
Further study details as provided by University of Turku:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided by University of Turku
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merja Soilu-Hanninen, MD, PhD, docent, neurologist, University of Turku, Department of Neurology, Turku, Finland |
| ClinicalTrials.gov Identifier: | NCT01339676 History of Changes |
| Other Study ID Numbers: | 2007-001958-99, EudraCT 2007-001958-99 |
| Study First Received: | April 19, 2011 |
| Last Updated: | May 18, 2011 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by University of Turku:
|
Vitamin D Multiple Sclerosis MRI Randomised Trial Finland |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta Interferons Interferon beta-1b Cholecalciferol Vitamin D |
Ergocalciferols Vitamins Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Micronutrients Growth Substances Bone Density Conservation Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 23, 2013