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
Sponsor:
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT01339676
First received: April 19, 2011
Last updated: May 18, 2011
Last verified: April 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339676

Locations
Finland
Turku University Hospital
Turku, Finland, FIN-20521
Sponsors and Collaborators
University of Turku
  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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Micronutrients
Growth Substances
Bone Density Conservation Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 25, 2014