Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis

Completed · Phase 2

Conditions studied: Juvenile Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00000429

Run by

Children's Hospital Medical Center, Cincinnati

People needed

192

Starts

1996-06-01

Expected to finish

2001-05-01

Last updated by the study team

2013-08-01

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• JRA Diagnosis by American College of Rheumatology diagnostic criteria
• Age 6-18 years

You may not qualify if…

• 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

Where it is running

• Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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