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

Phase 3

Completed

• Conditions: Juvenile Rheumatoid Arthritis
• Interventions: Dietary Supplement: Cholecalciferol; Dietary Supplement: Calcium; Dietary Supplement: Calcium and cholecalciferol; Drug: Placebo

• Registration Number: NCT00570934
• Lead Sponsor: University of Missouri-Columbia

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1995-03
• Primary Completion: 2002-02
• Study Completion: 2002-02
• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Juvenile Rheumatoid arthritis

Exclusion Criteria

• Steroid use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Calcium and cholecalciferol	Placebo	order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo
Calcium	Calcium and cholecalciferol	order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
Cholecalciferol	Calcium	order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium
Cholecalciferol	Calcium and cholecalciferol	order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium
Calcium	Cholecalciferol	order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
Cholecalciferol	Cholecalciferol	order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium
Placebo	Cholecalciferol	order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
Placebo	Calcium	order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
Placebo	Placebo	order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
Calcium	Calcium	order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
Calcium	Placebo	order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
Calcium and cholecalciferol	Calcium	order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo
Calcium and cholecalciferol	Calcium and cholecalciferol	order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo
Placebo	Calcium and cholecalciferol	order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
Calcium and cholecalciferol	Cholecalciferol	order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo
Cholecalciferol	Placebo	order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium

Primary Outcome Measures

Name	Time	Method
Percent true calcium absorption	After 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
Bone Mineralization by Dual Energy x-ray absorption	After 6 months treatment plus 3 month washout

Trial Locations

Locations (1)

University of Missouri Hospitals and clinics; 🇺🇸 Columbia, Missouri, United States