Completed

Phase 2
Age: 6Years - 18Years
All Genders
ID00000429

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

Official Title

Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis

Who Can Participate

Age: 6Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • JRA Diagnosis by American College of Rheumatology diagnostic criteria
  • Age 6-18 years
Not Eligible

You will not qualify if you...

  • 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

Trial Site Locations

Total: 1 location

1

Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Biochemical markers of bone turnover associated with calcium supplementation in children with juvenile rheumatoid arthritis: results of a double-blind, placebo-controlled intervention trial.

Ruy Carrasco, Daniel J Lovell, Edward H Giannini...

https://pubmed.ncbi.nlm.nih.gov/19035501