Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA
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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 1995
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1995
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 7, 2007
CompletedFirst Posted
Study publicly available on registry
December 11, 2007
CompletedOctober 10, 2016
October 1, 2016
6.9 years
December 7, 2007
October 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percent true calcium absorption
After 6 months of treatment
Secondary Outcomes (1)
Bone Mineralization by Dual Energy x-ray absorption
After 6 months treatment plus 3 month washout
Study Arms (4)
Placebo
EXPERIMENTALorder of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
Calcium
EXPERIMENTALorder of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
Cholecalciferol
EXPERIMENTALorder of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium
Calcium and cholecalciferol
EXPERIMENTALorder of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo
Interventions
2000IU Cholecalciferol P.O. Q.D.
1 gm calcium as calcium carbonate
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
Eligibility Criteria
You may qualify if:
- Juvenile Rheumatoid arthritis
You may not qualify if:
- Steroid use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri Hospitals and clinics
Columbia, Missouri, 65203, United States
Related Publications (1)
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. doi: 10.1002/art.23809.
PMID: 18821668DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura S Hillman, MD
University of Missouri-Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2007
First Posted
December 11, 2007
Study Start
March 1, 1995
Primary Completion
February 1, 2002
Study Completion
February 1, 2002
Last Updated
October 10, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share