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: November 23, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 17, 2007

Last Updated Date

November 23, 2011

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

Bone Mineral Density [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
SF-36 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Bone Mineral Density
SF-36

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Rheumatoid Arthritis
Hypovitaminosis D

Intervention ^ICMJE

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

Study Arm (s)

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

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]

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Rheumatology

Exclusion Criteria:

Bisphosphonate therapy

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00423358

Other Study ID Numbers ^ICMJE

2004-0011, 5 K23 AR050995-03

Has Data Monitoring Committee

Yes

Responsible Party

University of Wisconsin, Madison

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Karen E Hansen, MD

University of Wisconsin, Madison

Information Provided By

University of Wisconsin, Madison

Verification Date

November 2011

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

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