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

NCT00785473 | Completed Phase 4

• 2 other identifiers: MSvitD1EudraCT 2006-00427-11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Osteoporosis

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (7)

• Cytokine expression following vitamin D supplementation

  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)

  2 years

• Changes in parameters of lower extremity function over the 2 year study period

  2 years

• The number of relapses, the time to first relapse, the number of relapse-free patients

  2 years

• The number of patients without progression of disability judged by EDSS and

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

cholecalciferol, calcium carbonate

Dietary Supplement: cholecalciferol; Dietary Supplement: calcium carbonate

2

PLACEBO COMPARATOR

capsules not containing cholecalciferol, otherwise identical to Active comparator; calcium carbonate

Dietary Supplement: calcium carbonate

Interventions

cholecalciferol DIETARY_SUPPLEMENT

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

Also known as: Dekristol, Weifa-kalsium

1

calcium carbonate DIETARY_SUPPLEMENT

calcium carbonate 500 mg daily for 2 years

Also known as: Weifa-kalsium

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (4)

• Holmoy T, Lindstrom JC, Eriksen EF, Steffensen LH, Kampman MT. High dose vitamin D supplementation does not affect biochemical bone markers in multiple sclerosis - a randomized controlled trial. BMC Neurol. 2017 Apr 4;17(1):67. doi: 10.1186/s12883-017-0851-0.

  PMID: 28376767 DERIVED

• Rosjo E, Lossius A, Abdelmagid N, Lindstrom JC, Kampman MT, Jorgensen L, Sundstrom P, Olsson T, Steffensen LH, Torkildsen O, Holmoy T. Effect of high-dose vitamin D3 supplementation on antibody responses against Epstein-Barr virus in relapsing-remitting multiple sclerosis. Mult Scler. 2017 Mar;23(3):395-402. doi: 10.1177/1352458516654310. Epub 2016 Jul 11.

  PMID: 27325604 DERIVED

• Kampman MT, Steffensen LH, Mellgren SI, Jorgensen L. Effect of vitamin D3 supplementation on relapses, disease progression, and measures of function in persons with multiple sclerosis: exploratory outcomes from a double-blind randomised controlled trial. Mult Scler. 2012 Aug;18(8):1144-51. doi: 10.1177/1352458511434607. Epub 2012 Feb 21.

  PMID: 22354743 DERIVED

• Steffensen LH, Jorgensen L, Straume B, Mellgren SI, Kampman MT. Can vitamin D supplementation prevent bone loss in persons with MS? A placebo-controlled trial. J Neurol. 2011 Sep;258(9):1624-31. doi: 10.1007/s00415-011-5980-6. Epub 2011 Mar 13.

  PMID: 21400196 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Osteoporosis

Interventions

Cholecalciferol; Calcium Carbonate

Condition Hierarchy (Ancestors)

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; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Margitta T Kampman, MD, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 5, 2011

Record last verified: 2011-09

Locations

NO (1)