Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis - Full Text View

Sponsor:	University Hospital of North Norway
Information provided by (Responsible Party):	University Hospital of North Norway
ClinicalTrials.gov Identifier:	NCT00785473

Purpose

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	Intervention	Phase
Multiple Sclerosis, Osteoporosis	Dietary Supplement: cholecalciferol Dietary Supplement: calcium carbonate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Multiple Sclerosis Osteoporosis Vitamin D

Drug Information available for: Cholecalciferol Calcium gluconate Calcium carbonate Vitamin D

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:

Changes in BMD over the 2 year study period comparing treatment and placebo groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cytokine expression following vitamin D supplementation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Changes in parameters of lower extremity function over the 2 year study period [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The number of relapses, the time to first relapse, the number of relapse-free patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The number of patients without progression of disability judged by EDSS and [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Reported infections [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Ratings on a fatigue scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2008
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785473

Locations

Norway
University Hospital of North Norway
Tromsø, Norway, 9038

Sponsors and Collaborators

University Hospital of North Norway

Investigators

Principal Investigator:

Margitta T Kampman, MD, PhD

University Hospital of North Norway

More Information

No publications provided

Responsible Party:	University Hospital of North Norway
ClinicalTrials.gov Identifier:	NCT00785473 History of Changes
Other Study ID Numbers:	MSvitD1, EudraCT 2006-00427-11
Study First Received:	November 4, 2008
Last Updated:	September 2, 2011
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:

Multiple Sclerosis
Osteoporosis
Sclerosis
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
Pathologic Processes

Calcium, Dietary
Cholecalciferol
Vitamin D
Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012