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NCT00570934 Clinical Trial

Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA

Juvenile Rheumatoid Arthritis Clinical Trial

Official title:
Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00570934
Other study ID # 5387
Secondary ID
Status Completed
Phase Phase 3
First received December 7, 2007
Last updated October 7, 2016
Start date March 1995
Est. completion date February 2002

Study information
Verified date October 2016
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Description:

Supplementation With 2000 IU Vitamin D, 1 gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 2002
Est. primary completion date February 2002
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 15 Years
Eligibility Inclusion Criteria:

- Juvenile Rheumatoid arthritis

Exclusion Criteria:

- Steroid use

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Cholecalciferol
2000IU Cholecalciferol P.O. Q.D.
• Calcium
1 gm calcium as calcium carbonate
• Calcium and cholecalciferol
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
Drug:
• Placebo
Placebo

Locations
Country Name City State
United States University of Missouri Hospitals and clinics Columbia Missouri

Sponsors (1)
Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent true calcium absorption After 6 months of treatment No
Secondary Bone Mineralization by Dual Energy x-ray absorption After 6 months treatment plus 3 month washout No
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Terminated NCT03781375 - Etanercept Plus Methotrexate Versus Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis Phase 3