Supplimentation With 2000IU Vitamin D, 1gm Calcium or Both on Calcium Absorption and BMC in Children With JRA - Tabular View

Tracking Information

First Received Date ^ICMJE

December 7, 2007

Last Updated Date

December 10, 2007

Start Date ^ICMJE

March 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Percent true calcium absorption [ Time Frame: After 6 months of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00570934 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Bone Mineralization by Dual Energy x-ray absorption [ Time Frame: After 6 months treatment plus 3 month washout ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Supplimentation With 2000IU Vitamin D, 1gm Calcium or Both on Calcium Absorption and BMC in Children With JRA

Official Title ^ICMJE

Effect ofSupplimentation With 2000IU Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis

Brief Summary

2000IU vitamin D, 1gm calcium, or both given to children with Juvenile Rheumatoid Arthritis may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Juvenile Rheumatoid Arthritis

Intervention ^ICMJE

Dietary Supplement: Cholecalciferol
Dietary Supplement: Calcium Carbonate
Dietary Supplement: 2000IU cholecalciferol plus 1 gm calcium

Study Arms / Comparison Groups

Experimental: order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
Experimental: order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
Experimental: order of treatments cholechalciferol, calcium and Cholechalciferol, placebo, and calcium
Experimental: order of treatment calcium and cholechalciferol, cholecalciferol, calcium, placebo

Publications *

Hillman LS, Cassidy JT, Chanetsa F, Hewett JE, Higgins BJ, Robertson JD. Percent true calcium absorption, mineral metabolism, and bone mass in children with arthritis: effect of supplementation with vitamin D3 and calcium. Arthritis Rheum. 2008 Oct;58(10):3255-63.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Juvenile Rheumatoid arthritis

Exclusion Criteria:

Steroid use

Gender

Both

Ages

3 Years to 15 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 ID ^ICMJE

NCT00570934

Responsible Party

Laura S. Hillman MD, University of Missouri

Study ID Numbers ^ICMJE

hillmanlJRA

Study Sponsor ^ICMJE

University of Missouri-Columbia

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Laura S Hillman, MD

University of Missouri-Columbia

Information Provided By

University of Missouri-Columbia

Verification Date

December 2007

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