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Trial record 22 of 43 for:    "multiple sclerosis" AND "vitamin D"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 4, 2008
First Posted Date  ICMJE November 5, 2008
Last Update Posted Date September 5, 2011
Study Start Date  ICMJE January 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2008)
Changes in BMD over the 2 year study period comparing treatment and placebo groups [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00785473 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2008)
  • Cytokine expression following vitamin D supplementation [ Time Frame: 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) [ Time Frame: 2 years ]
  • Changes in parameters of lower extremity function over the 2 year study period [ Time Frame: 2 years ]
  • The number of relapses, the time to first relapse, the number of relapse-free patients [ Time Frame: 2 years ]
  • The number of patients without progression of disability judged by EDSS and [ Time Frame: 2 years ]
  • Reported infections [ Time Frame: 2 years ]
  • Ratings on a fatigue scale [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis
Official Title  ICMJE Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Multiple Sclerosis, Osteoporosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    cholecalciferol, calcium carbonate
    Interventions:
    • Dietary Supplement: cholecalciferol
    • Dietary Supplement: calcium carbonate
  • Placebo Comparator: 2
    capsules not containing cholecalciferol, otherwise identical to Active comparator; calcium carbonate
    Intervention: Dietary Supplement: calcium carbonate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 4, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00785473
Other Study ID Numbers  ICMJE MSvitD1
EudraCT 2006-00427-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Margitta T Kampman, MD, PhD University Hospital of North Norway
PRS Account University Hospital of North Norway
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP