Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis
Status:
Completed
Trial end date:
2001-05-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)