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Sponsors and Collaborators: |
Arkansas Children's Hospital Research Institute University of Arkansas United States Department of Agriculture |
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Information provided by: | Arkansas Children's Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT00616395 |
Beginnings is a long-term nutrition research study of infants/children from birth through school age. Moms can enroll their healthy babies between 4 - 8 weeks old, once they have decided on the right feeding type for their baby - breast milk, milk-based formula, or soy-based formula. Moms and babies come to the Arkansas Children's Nutrition Center for up to eight study visits during the first year of life, at 1-, 2-, 3-, 4-, 5-, 6-, 9-, and 12 months of age, then annually until 6 years of age. At each visit, we measure the growth, brain function, development and diet of the infant/child. At some visits, we also assess body composition (percent body fat), general development and behavior, and the size of some organs with an ultrasound.
Condition |
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Healthy |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children |
Plasma and urine may be collected from some study participants.
Estimated Enrollment: | 600 |
Study Start Date: | September 2002 |
Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Infants exclusively fed breast milk
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2
Infants exclusively fed milk-based formula
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3
Infants exclusively fed soy-based formula
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Ages Eligible for Study: | 1 Month to 3 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Healthy infants from the greater Little Rock area.
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Stokes | 866-423-1311 | acncstudies@uams.edu |
Contact: Kerry Wood, M.S., L.P.E. | 501-364-3216 | woodkerryn@uams.edu |
United States, Arkansas | |
Arkansas Children's Nutrition Center | Recruiting |
Little Rock, Arkansas, United States, 72202 | |
Contact: Aline Andres, Ph.D. 501-364-3301 andresaline@uams.edu | |
Sub-Investigator: R Terry Pivik, Ph.D. | |
Sub-Investigator: Martin JJ Ronis, Ph.D. | |
Sub-Investigator: Mary Beth Moore, M.D. | |
Sub-Investigator: Joanne Szabo, M.D. | |
Sub-Investigator: Patrick H Casey, M.D. | |
Sub-Investigator: Aline Andres, Ph.D |
Principal Investigator: | Thomas M Badger, Ph.D. | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Science ( Thomas M. Badger, Ph.D. ) |
Study ID Numbers: | 07130, CRIS#251-51000-005-03S |
Study First Received: | December 31, 2007 |
Last Updated: | August 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00616395 History of Changes |
Health Authority: | United States: Institutional Review Board |
Infant Nutrition Soy Phytochemicals Infant Body Composition |
Brain Function Cognition and Development Healthy Infants |
Healthy |