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| Tracking Information | |||||
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| First Received Date ICMJE | January 17, 2007 | ||||
| Last Updated Date | June 19, 2009 | ||||
| Start Date ICMJE | February 2005 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Bone Turnover [ Time Frame: 1 Year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Bone Turnover | ||||
| Change History | Complete list of historical versions of study NCT00423358 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Hypovitaminosis D in Rheumatoid Arthritis | ||||
| Official Title ICMJE | Treatment of Hypovitaminosis D in Rheumatoid Arthritis | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | Experimental: Vitamin D | ||||
| 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] | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 22 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00423358 | ||||
| Responsible Party | Karen E. Hansen, MD, University of Wisconsin | ||||
| Study ID Numbers ICMJE | 2004-0011, 5 K23 AR050995-03 | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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