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

May 18, 2011 updated by: University of Turku

Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, FIN-20521
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • Vitamin D
PLACEBO_COMPARATOR: 2
Identically appearing once weekly peroral capsules
Drug: Placebo capsules
Identically appearing once weekly peroral placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ANTICIPATED)

May 1, 2011

Study Completion (ANTICIPATED)

June 1, 2011

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (ESTIMATE)

April 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-001958-99
  • EudraCT 2007-001958-99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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