Treatment of Hypovitaminosis D in Rheumatoid Arthritis
2 other identifiers
interventional
22
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable rheumatoid-arthritis
Started Feb 2005
Typical duration for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
August 24, 2015
CompletedAugust 24, 2015
July 1, 2015
3.5 years
January 17, 2007
May 29, 2015
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parathyroid Hormone Level
Serum parathyroid hormone level
1 Year
Secondary Outcomes (2)
Bone Mineral Density
1 Year
Short Form 36 Survey
1 Year
Study Arms (2)
vitamin D
ACTIVE COMPARATORergocalciferol 50,000 IU Twice monthly
placebo
PLACEBO COMPARATORmatching placebo tablet
Interventions
Eligibility Criteria
You may qualify if:
- Rheumatology
You may not qualify if:
- Bisphosphonate therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53705, United States
Related Publications (2)
Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Engelke JA, Shafer MM. Vitamin D insufficiency: disease or no disease? J Bone Miner Res. 2008 Jul;23(7):1052-60. doi: 10.1359/jbmr.080230.
PMID: 18302509RESULTHansen KE, Bartels CM, Gangnon RE, Jones AN, Gogineni J. An evaluation of high-dose vitamin D for rheumatoid arthritis. J Clin Rheumatol. 2014 Mar;20(2):112-4. doi: 10.1097/RHU.0000000000000072. No abstract available.
PMID: 24561419RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karen E Hansen, MD, MS
- Organization
- University of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Karen E Hansen, MD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2007
First Posted
January 18, 2007
Study Start
February 1, 2005
Primary Completion
August 1, 2008
Study Completion
February 1, 2009
Last Updated
August 24, 2015
Results First Posted
August 24, 2015
Record last verified: 2015-07