Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis

September 2, 2011 updated by: University Hospital of North Norway

Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study

Several studies have shown that bone mineral density (BMD) at the femoral neck decreases with increasing physical handicap (EDSS-score) in MS patients. Possible explanations are less weightbearing exercise or less UV-exposure resulting in reduced vitamin D generation in the skin. Prevention of osteoporosis is a high priority, because treatment of the established disease remains sub-optimal.

We have designed a double-blind randomised controlled trial of two years' duration including 90-100 persons with MS age 18-50 to assess whether supplementation with vitamin D, given as a weekly dose of 20,000 IU cholecalciferol, can prevent bone loss.

The primary objective of this study is to determine changes in BMD over the 2 year study period comparing treatment and placebo groups.

The most important secondary objective is to determine cytokine profiles in blood samples. We will also assess parameters related to vitamin D status and physical performance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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

  • Norway
      • Tromsø, Norway, 9038
        • University Hospital of North Norway

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 50 years
  • EDSS < 4.0 (able to walk without rest some 500 m)
  • Women have to be premenopausal
  • MS according to the McDonald criteria; prepared and considered able to follow the protocol; using appropriate contraceptive methods (women of childbearing potential)
  • Having given written informed consent.

Exclusion Criteria:

  • Pregnancy or unwillingness to use contraception; alcohol or drug abuse
  • Use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses
  • Known allergy to cholecalciferol or arachis oil (peanuts)
  • Therapy with digitalis, calcitonin, active vitamin D3 analogues, fluoride, or bisphosphonates during the previous 12 months
  • Any condition predisposing to hypercalcaemia
  • Nephrolithiasis or renal insufficiency
  • Presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began; a history of nephrolithiasis during the previous five years.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
cholecalciferol, calcium carbonate
Dietary supplement: cholecalciferol
cholecalciferol capsules, 20,000 IU weekly for 2 years and calcium carbonate 500 mg daily
Other Names:
  • Dekristol, Weifa-kalsium
Dietary supplement: calcium carbonate
calcium carbonate 500 mg daily for 2 years
Other Names:
  • Weifa-kalsium
Placebo Comparator: 2
capsules not containing cholecalciferol, otherwise identical to Active comparator; calcium carbonate
Dietary supplement: calcium carbonate
calcium carbonate 500 mg daily for 2 years
Other Names:
  • Weifa-kalsium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in BMD over the 2 year study period comparing treatment and placebo groups
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cytokine expression following vitamin D supplementation
Time Frame: 2 years
2 years
Contribution of vitamin D from different sources (generation in the skin, diet and supplements) to serum 25(OH) vitamin D (vitamin D status)
Time Frame: 2 years
2 years
Changes in parameters of lower extremity function over the 2 year study period
Time Frame: 2 years
2 years
The number of relapses, the time to first relapse, the number of relapse-free patients
Time Frame: 2 years
2 years
The number of patients without progression of disability judged by EDSS and
Time Frame: 2 years
2 years
Reported infections
Time Frame: 2 years
2 years
Ratings on a fatigue scale
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

University Hospital of North Norway

Investigators

  • Principal Investigator: Margitta T Kampman, MD, PhD, University Hospital of North Norway

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

January 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 4, 2008

First Posted (Estimate)

November 5, 2008

Study Record Updates

Last Update Posted (Estimate)

September 5, 2011

Last Update Submitted That Met QC Criteria

September 2, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSvitD1
  • EudraCT 2006-00427-11

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.

Clinical Trials on Multiple Sclerosis, Osteoporosis

Clinical Trials on cholecalciferol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe