Search / Trial NCT00000429

Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jan 18, 2000

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Jra Osteopenia Dietary Calcium Diet Therapy Bone Density Ossification Biomarker Dietary Supplement

Description

This is a randomized, double-blind, placebo-controlled trial of 24 months in which juvenile rheumatoid arthritis (JRA) patients will take either an oral calcium supplement of 1,000 mg elemental calcium per day or a matching placebo containing no calcium (Ca), plus one multivitamin per day. We hypothesize that patients receiving calcium supplementation will demonstrate at least a 10 percent greater increase in total body bone mineral density compared to those treated with placebo. We will evaluate patients at Children's Hospital Medical Center (CHMC) every 6 months for 2 years. We will also...

Gender

All

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

Attachments

readout_NCT00000429_2023-12-10.pdf

4.5 MB

NCT00000429_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Cincinnati, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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