Treatment of Hypovitaminosis D in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00423358
First received: January 17, 2007
Last updated: June 3, 2014
Last verified: June 2014

January 17, 2007
June 3, 2014
February 2005
August 2008   (final data collection date for primary outcome measure)
Bone Turnover [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Bone Turnover
Complete list of historical versions of study NCT00423358 on ClinicalTrials.gov Archive Site
  • Bone Mineral Density [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Short Form 36 Survey [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Bone Mineral Density
  • SF-36
Not Provided
Not Provided
 
Treatment of Hypovitaminosis D in Rheumatoid Arthritis
Treatment of Hypovitaminosis D in Rheumatoid Arthritis

This study recruits individuals with rheumatoid arthritis (RA) and low vitamin D concentrations. Subjects are dosed with vitamin D or placebo for one year. Primary outcome is change in bone turnover markers, additionally, bone mineral density and parameters of RA status are evaluated throughout the study.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Hypovitaminosis D
  • Dietary Supplement: Vitamin D
    Ergocalciferol 50,000 IU loading dose then twice monthly for one year
    Other Name: ergocalciferol
  • Dietary Supplement: placebo
    matching placebo
    Other Name: placebo
  • Active Comparator: vitamin D
    ergocalciferol 50,000 IU Twice monthly
    Intervention: Dietary Supplement: Vitamin D
  • Placebo Comparator: placebo
    matching placebo tablet
    Intervention: Dietary Supplement: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
February 2009
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Rheumatology

Exclusion Criteria:

  • Bisphosphonate therapy
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00423358
2004-0011, 5 K23 AR050995-03
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Karen E Hansen, MD University of Wisconsin, Madison
University of Wisconsin, Madison
June 2014

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