Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA
Primary Purpose
Juvenile Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Calcium
Calcium and cholecalciferol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Juvenile Rheumatoid arthritis
Exclusion Criteria:
- Steroid use
Sites / Locations
- University of Missouri Hospitals and clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Calcium
Cholecalciferol
Calcium and cholecalciferol
Arm Description
order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium
order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo
Outcomes
Primary Outcome Measures
Percent true calcium absorption
Secondary Outcome Measures
Bone Mineralization by Dual Energy x-ray absorption
Full Information
NCT ID
NCT00570934
First Posted
December 7, 2007
Last Updated
October 7, 2016
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00570934
Brief Title
Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
February 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Experimental
Arm Description
order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol
Arm Title
Calcium
Arm Type
Experimental
Arm Description
order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol
Arm Title
Cholecalciferol
Arm Type
Experimental
Arm Description
order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium
Arm Title
Calcium and cholecalciferol
Arm Type
Experimental
Arm Description
order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Intervention Description
2000IU Cholecalciferol P.O. Q.D.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium
Intervention Description
1 gm calcium as calcium carbonate
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium and cholecalciferol
Intervention Description
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percent true calcium absorption
Time Frame
After 6 months of treatment
Secondary Outcome Measure Information:
Title
Bone Mineralization by Dual Energy x-ray absorption
Time Frame
After 6 months treatment plus 3 month washout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Juvenile Rheumatoid arthritis
Exclusion Criteria:
Steroid use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura S Hillman, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Hospitals and clinics
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18821668
Citation
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.
Results Reference
derived
Learn more about this trial
Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA
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