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

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ClinicalTrials.gov Identifier: NCT00785473
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : September 5, 2011
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Osteoporosis Dietary Supplement: cholecalciferol Dietary Supplement: calcium carbonate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study
Study Start Date : January 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Dekristol, Weifa-kalsium

Dietary Supplement: calcium carbonate
calcium carbonate 500 mg daily for 2 years
Other Name: 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 Name: Weifa-kalsium


Outcome Measures
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Primary Outcome Measures :
  1. Changes in BMD over the 2 year study period comparing treatment and placebo groups [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Cytokine expression following vitamin D supplementation [ Time Frame: 2 years ]
  2. 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 ]
  3. Changes in parameters of lower extremity function over the 2 year study period [ Time Frame: 2 years ]
  4. The number of relapses, the time to first relapse, the number of relapse-free patients [ Time Frame: 2 years ]
  5. The number of patients without progression of disability judged by EDSS and [ Time Frame: 2 years ]
  6. Reported infections [ Time Frame: 2 years ]
  7. Ratings on a fatigue scale [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT00785473


Locations
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Norway
University Hospital of North Norway
Tromsø, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
Investigators
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Principal Investigator: Margitta T Kampman, MD, PhD University Hospital of North Norway
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00785473    
Other Study ID Numbers: MSvitD1
EudraCT 2006-00427-11
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Cholecalciferol
Vitamin D
Vitamins
Osteoporosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Micronutrients
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents