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Study of Early Infant Diet on Growth and Development (Beginnings)
This study is currently recruiting participants.
Verified by Arkansas Children's Hospital Research Institute, August 2009
First Received: December 31, 2007   Last Updated: August 19, 2009   History of Changes
Sponsors and Collaborators: Arkansas Children's Hospital Research Institute
University of Arkansas
United States Department of Agriculture
Information provided by: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00616395
  Purpose

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
Healthy

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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
1
Infants exclusively fed breast milk
2
Infants exclusively fed milk-based formula
3
Infants exclusively fed soy-based formula

  Eligibility

Ages Eligible for Study:   1 Month to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy infants from the greater Little Rock area.

Criteria

Inclusion Criteria:

  • Healthy Infants
  • Weigh 6-9# at birth
  • Exclusively fed breast milk, milk-based formula, soy-based formula
  • Mother over 18 years of age

Exclusion Criteria:

  • Unhealthy pregnancy
  • Significant soy consumption of the mother during pregnancy/lactation
  • Any illness in the child thought to interfere with the study parameters as determined by the investigators
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616395

Contacts
Contact: Andrea Stokes 866-423-1311 acncstudies@uams.edu
Contact: Kerry Wood, M.S., L.P.E. 501-364-3216 woodkerryn@uams.edu

Locations
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            
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
University of Arkansas
United States Department of Agriculture
Investigators
Principal Investigator: Thomas M Badger, Ph.D. University of Arkansas
  More Information

No publications provided

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

Keywords provided by Arkansas Children's Hospital Research Institute:
Infant Nutrition
Soy Phytochemicals
Infant Body Composition
Brain Function
Cognition and Development
Healthy Infants

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on September 10, 2009