Physical Activity Clinical Trial
Official title:
Calcium Modifies Bone Response to Activity in Children
Verified date | June 2013 |
Source | South Dakota State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
Doctors recommend that young children participate in daily physical activity to promote bone health. However, studies in adults show that physical activity and increased calcium intake cause noticeable benefits for bone health only when both factors occur together. The goal of this study is to find out whether calcium intake changes the response of bone to activity in children 3 to 4 years old. Children will participate in one of two programs conducted in childcare centers 5 days a week for 1 year. One program will involve activities that use large muscles (gross motor activity). The other will involve activities using small muscles (fine motor activity). We will give a calcium supplement (1 gram per day) to half of the children in each program and give the other half an inactive pill. We will measure bone mass and bone mineral density at the beginning and end of the study. We will take measurements 12 months after the program's completion to see if physical activity and/or calcium supplements have long-term effects on bone mineral density and physical activity.
Status | Completed |
Enrollment | 224 |
Est. completion date | March 2003 |
Est. primary completion date | February 2003 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 3 Years to 4 Years |
Eligibility |
Inclusion Criteria: - Enrolled in participating childcare center. - Does not plan to attend kindergarten or withdraw from center in the next 12 months. Exclusion Criteria: - Chronic disease that may interfere with growth and bone mass accretion (cystic fibrosis, liver disease, asthma that is being treated with steroids, juvenile rheumatoid arthritis, immobilization). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | South Dakota State University | Brookings | South Dakota |
Lead Sponsor | Collaborator |
---|---|
South Dakota State University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Specker B, Binkley T. Randomized trial of physical activity and calcium supplementation on bone mineral content in 3- to 5-year-old children. J Bone Miner Res. 2003 May;18(5):885-92. — View Citation
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