Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Osteoporosis
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
cholecalciferol
calcium carbonate
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Sclerosis, Osteoporosis
Eligibility 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.
Sites / Locations
- University Hospital of North Norway
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
cholecalciferol, calcium carbonate
capsules not containing cholecalciferol, otherwise identical to Active comparator; calcium carbonate
Outcomes
Primary Outcome Measures
Changes in BMD over the 2 year study period comparing treatment and placebo groups
Secondary Outcome Measures
Cytokine expression following vitamin D supplementation
Contribution of vitamin D from different sources (generation in the skin, diet and supplements) to serum 25(OH) vitamin D (vitamin D status)
Changes in parameters of lower extremity function over the 2 year study period
The number of relapses, the time to first relapse, the number of relapse-free patients
The number of patients without progression of disability judged by EDSS and
Reported infections
Ratings on a fatigue scale
Full Information
NCT ID
NCT00785473
First Posted
November 4, 2008
Last Updated
September 2, 2011
Sponsor
University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT00785473
Brief Title
Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis
Official Title
Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
cholecalciferol, calcium carbonate
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
capsules not containing cholecalciferol, otherwise identical to Active comparator; calcium carbonate
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
Dekristol, Weifa-kalsium
Intervention Description
cholecalciferol capsules, 20,000 IU weekly for 2 years and calcium carbonate 500 mg daily
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium carbonate
Other Intervention Name(s)
Weifa-kalsium
Intervention Description
calcium carbonate 500 mg daily for 2 years
Primary Outcome Measure Information:
Title
Changes in BMD over the 2 year study period comparing treatment and placebo groups
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Cytokine expression following vitamin D supplementation
Time Frame
2 years
Title
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
Title
Changes in parameters of lower extremity function over the 2 year study period
Time Frame
2 years
Title
The number of relapses, the time to first relapse, the number of relapse-free patients
Time Frame
2 years
Title
The number of patients without progression of disability judged by EDSS and
Time Frame
2 years
Title
Reported infections
Time Frame
2 years
Title
Ratings on a fatigue scale
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margitta T Kampman, MD, PhD
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
28376767
Citation
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.
Results Reference
derived
PubMed Identifier
27325604
Citation
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.
Results Reference
derived
PubMed Identifier
22354743
Citation
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.
Results Reference
derived
PubMed Identifier
21400196
Citation
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.
Results Reference
derived
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Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis
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