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NCT Number: NCT00785473

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

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.

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Key information

Conditions

Multiple Sclerosis, Osteoporosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Bone Diseases Bone Diseases, Metabolic Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Metabolic Diseases Multiple Sclerosis Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of North Norway

Tromsø, 9038, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cholecalciferol

Dietary Supplement

cholecalciferol capsules, 20,000 IU weekly for 2 years and calcium carbonate 500 mg daily

Other names: Dekristol, Weifa-kalsium

Calcium Carbonate

Dietary Supplement

calcium carbonate 500 mg daily for 2 years

Other names: Weifa-kalsium

Primary outcomes

  1. Changes in BMD over the 2 year study period comparing treatment and placebo groups

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 5, 2008
Registry last updated
Sep 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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