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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
University of Turku

Tracking Information
First Submitted Date  ICMJE April 19, 2011
First Posted Date  ICMJE April 21, 2011
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01339676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)
Official Title  ICMJE Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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
  • Drug: Placebo capsules
    Identically appearing once weekly peroral placebo capsules
Study Arms  ICMJE
  • 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
    Intervention: Drug: Colecalciferol
  • Placebo Comparator: 2
    Identically appearing once weekly peroral capsules
    Intervention: Drug: Placebo capsules
Publications * Soilu-Hänninen M, Aivo J, Lindström BM, Elovaara I, Sumelahti ML, Färkkilä 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 β-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 20, 2011)
70
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01339676
Other Study ID Numbers  ICMJE 2007-001958-99
EudraCT 2007-001958-99
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merja Soilu-Hanninen, MD, PhD, docent, neurologist, University of Turku, Department of Neurology, Turku, Finland
Study Sponsor  ICMJE University of Turku
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Turku
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP