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
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Hypovitaminosis D
Dietary Supplement: Vitamin D
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Hypovitaminosis D in Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Bone Turnover [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: February 2005
Study Completion Date: February 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamin D
ergocalciferol 50,000 IU Twice monthly
Dietary Supplement: Vitamin D
Ergocalciferol 50,000 IU loading dose then twice monthly for one year
Other Name: ergocalciferol
Placebo Comparator: placebo
matching placebo tablet
Dietary Supplement: placebo
matching placebo
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatology

Exclusion Criteria:

  • Bisphosphonate therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423358

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Karen E Hansen, MD University of Wisconsin, Madison
  More Information

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00423358     History of Changes
Other Study ID Numbers: 2004-0011, 5 K23 AR050995-03
Study First Received: January 17, 2007
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
rheumatoid arthritis
hypovitaminosis D
bone turnover
ergocalciferol

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Avitaminosis
Rickets
Vitamin D Deficiency
Autoimmune Diseases
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Connective Tissue Diseases
Deficiency Diseases
Immune System Diseases
Joint Diseases
Malnutrition
Metabolic Diseases
Musculoskeletal Diseases
Nutrition Disorders
Rheumatic Diseases
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014