Physical Activity, Calcium, and Bone in Children
Calcium Modifies Bone Response to Activity in Children
2 other identifiers
interventional
224
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 1998
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedJune 4, 2013
June 1, 2013
4.8 years
November 3, 1999
June 3, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Enrolled in participating childcare center.
- Does not plan to attend kindergarten or withdraw from center in the next 12 months.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Dakota State University
Brookings, South Dakota, 57007, United States
Related Publications (1)
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. doi: 10.1359/jbmr.2003.18.5.885.
PMID: 12733728BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bonny Specker, PhD
South Dakota State University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
April 1, 1998
Primary Completion
February 1, 2003
Study Completion
March 1, 2003
Last Updated
June 4, 2013
Record last verified: 2013-06