Physical Activity, Calcium, and Bone in Children
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|ClinicalTrials.gov Identifier: NCT00000415|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : June 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity Nutrition||Procedure: Physical activity Drug: Calcium supplement||Phase 2|
Participation in daily physical activity programs by young children is currently recommended as a means of promoting bone health. Results from studies of adults indicate that beneficial effects of either physical activity or calcium (Ca) intake may be apparent only when both these factors are present. Our results in infants indicate that physical activity combined with a low Ca diet may be detrimental in terms of bone mass accretion. The overall objective of this study is to determine whether Ca intake modifies the bone response to activity in young children 3 to 4 years of age.
Our hypotheses are that (1) the increase in bone mass resulting from a physical activity program will be more pronounced in children randomized to receive a Ca supplement compared to the increase in children randomized to receive a placebo; and (2) 12 months after cessation of the activity program, bone mass will remain higher in children randomized to gross motor activity compared to children randomized to fine motor activity, and the beneficial effect of Ca supplementation will persist only among children randomized to gross motor activity. We will test these hypotheses in a randomized 2 x 2 factorial trial in 3- to 4-year-old children. We will randomize children into either a gross motor or fine motor activity program that will be conducted in childcare centers 5 days a week for 1 year. We will further randomize each child into either a Ca supplement (1 g/d) or placebo group.
The primary outcomes of the study are bone mass accretion and changes in bone mineral density, which we will determine by dual energy x-ray absorptiometry at the beginning and end of the study. We will do activity assessments throughout the study period to determine whether participation in the gross motor activity group also increases spontaneous activity in these children. Anthropometric measurements and dietary information will allow us to statistically control for these potential confounders. We will obtain additional bone mass and physical activity measurements 12 months after completion of the program to determine if these interventions have long-term effects on bone mineral density and physical activity.
A finding of beneficial effects of Ca supplementation or physical activity, either independent of each other or in combination, will lay the groundwork for devising prevention strategies within the educational system that optimize bone health beginning early in life. However, we may find that increased physical activity in the presence of a low to moderate Ca intake may have a detrimental effect on bone mass accretion during periods of rapid growth.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||224 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Calcium Modifies Bone Response to Activity in Children|
|Study Start Date :||April 1998|
|Actual Primary Completion Date :||February 2003|
|Actual Study Completion Date :||March 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000415
|United States, South Dakota|
|South Dakota State University|
|Brookings, South Dakota, United States, 57007|
|Principal Investigator:||Bonny Specker, PhD||South Dakota State University|