Treatment of Hypovitaminosis D in Rheumatoid Arthritis

This study has been completed.

First Received: January 17, 2007 Last Updated: June 19, 2009 History of Changes

Sponsor:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00423358

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	Drug: Vitamin D - ergocalciferol Other: placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment of Hypovitaminosis D in Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Minerals Rheumatoid Arthritis Rickets

Drug Information available for: Ergocalciferol Vitamin D

U.S. FDA Resources

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 ]
SF-36 [ 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
1: Experimental Vitamin D	Drug: Vitamin D - ergocalciferol
2: Placebo Comparator	Other: 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

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:

Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Engelke JA, Shafer MM. Vitamin D Insufficiency: Disease or No Disease? J Bone Miner Res. 2008 Feb 26; [Epub ahead of print]

Responsible Party:	University of Wisconsin ( Karen E. Hansen, MD )
Study ID Numbers:	2004-0011, 5 K23 AR050995-03
Study First Received:	January 17, 2007
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00423358 History of Changes
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:

Avitaminosis
Physiological Effects of Drugs
Arthritis, Rheumatoid
Bone Density Conservation Agents
Bone Diseases
Calcium Metabolism Disorders
Malnutrition
Musculoskeletal Diseases
Arthritis
Vitamins
Connective Tissue Diseases
Nutrition Disorders
Micronutrients

Deficiency Diseases
Vitamin D Deficiency
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Growth Substances
Joint Diseases
Ergocalciferols
Bone Diseases, Metabolic
Rheumatic Diseases
Pharmacologic Actions
Vitamin D
Rickets

ClinicalTrials.gov processed this record on November 05, 2009