Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis

NCT00000429 | Completed Phase 2

• 2 other identifiers: P60AR044059NIAMS-020
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Juvenile Rheumatoid Arthritis

Keywords

JRA; Osteopenia; Dietary calcium; Diet therapy; Bone density; Ossification; Biomarker; Dietary supplement

Interventions

Calcium carbonate DRUG

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Carrasco R, Lovell DJ, Giannini EH, Henderson CJ, Huang B, Kramer S, Ranz J, Heubi J, Glass D. Biochemical markers of bone turnover associated with calcium supplementation in children with juvenile rheumatoid arthritis: results of a double-blind, placebo-controlled intervention trial. Arthritis Rheum. 2008 Dec;58(12):3932-40. doi: 10.1002/art.24041.

  PMID: 19035501 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile; Bone Diseases, Metabolic

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Daniel J. Lovell, MD

  Children's Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: June 1, 1996
• Study Completion: May 1, 2001
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

US (1)