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

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ClinicalTrials.gov Identifier: NCT01339676
Recruitment Status : Unknown
Verified April 2011 by University of Turku.
Recruitment status was:  Active, not recruiting
First Posted : April 21, 2011
Last Update Posted : May 19, 2011
Information provided by:
University of Turku

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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 ]

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339676

Turku University Hospital
Turku, Finland, FIN-20521
Sponsors and Collaborators
University of Turku

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
First Posted: April 21, 2011    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: April 2011

Keywords provided by University of Turku:
Vitamin D
Multiple Sclerosis
Randomised Trial

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Interferon beta-1b
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Adjuvants, Immunologic