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| Tracking Information | |||||
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| First Received Date ICMJE | November 3, 1999 | ||||
| Last Updated Date | December 28, 2006 | ||||
| Start Date ICMJE | April 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00000415 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Physical Activity, Calcium, and Bone in Children | ||||
| Official Title ICMJE | Calcium Modifies Bone Response to Activity in Children | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 224 | ||||
| Completion Date | August 2001 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 4 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00000415 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01 AR45310, NIAMS-010 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | February 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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