Completed
Calcium Supplementation for Bone Mineralization in Juvenile Rheumatoid Arthritis JRA
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2013-08-01
192
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study looks at the effects of taking calcium pills on bone health in young people with juvenile rheumatoid arthritis (JRA). In this 2-year study, children aged 6-18 who have JRA will take either a calcium supplement or a matching placebo (inactive or "dummy" pill) containing no calcium. During the study, researchers and patients will not know if a patient is taking calcium or placebo. We believe that patients who take calcium supplements will have at least a 10 percent greater increase in total body bone mineral density compared to patients who take the placebo. We will evaluate patients at Children's Hospital Medical Center every 6 months for 2 years. During this 2-year period, participants in the study will take one multivitamin containing 400 IU (international units) of vitamin D and either 1,000 mg of calcium carbonate (Tums tablets) by mouth or a matching placebo once a day. We will check patients 6 and 18 months after the 2-year treatment period to find out if people in the Tums-treated group maintain any increases in bone formation that occurred during the 2-year treatment period.
CONDITIONS
Brief Title
Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
Inclusion Criteria:
- JRA Diagnosis by American College of Rheumatology diagnostic criteria
- Age 6-18 years
Exclusion Criteria:
- Taking calcium supplements or calcium- containing antacids
- Taken systemic corticosteroids in the prior 3 months
- Use of oral contraceptives
- Smoker
- Have been or currently pregnant
- Have another chronic illness that affects growth or bone mineralization (for example, Down's Syndrome, inflammatory bowel disease, steroid-dependent asthma)
- Fasting random urinary calcium/creatinine ratio > 0.2
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