Trial record 1 of 1 for:    NCT00616395
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Study of Early Infant Diet on Growth and Development (Beginnings)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616395
Recruitment Status : Active, not recruiting
First Posted : February 15, 2008
Last Update Posted : August 3, 2018
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Brief Summary:
The purpose of this study is to characterize physical growth, body composition, dietary intake, neurobehavioral development, and brain function of infants and children fed mostly breast-milk, milk-based formula or soy-based formula during their first year of life. Children are followed from age 2 months to age 6 years.

Condition or disease Intervention/treatment
Healthy Device: No intervention

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children
Actual Study Start Date : September 2002
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : December 2019

Group/Cohort Intervention/treatment
no grouping
IDE used for outcome measurement not for an intervention.
Device: No intervention

Primary Outcome Measures :
  1. Growth and development [ Time Frame: yearly, 1-6 years ]

Biospecimen Retention:   Samples Without DNA
Plasma, urine, and stool may be collected from some study participants.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy infants

Inclusion Criteria:

  • Healthy Infants
  • Birth weight = 6 to 9 lbs
  • Mostly fed breast milk, milk-based formula, soy-based formula
  • Mother over 18 years of age

Exclusion Criteria:

  • Unhealthy pregnancy
  • Illness during pregnancy or for the child that could interfere with the study parameters

Information from the National Library of Medicine

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 identifier (NCT number): NCT00616395

United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Principal Investigator: Aline Andres, Ph.D. University of Arkansas

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Arkansas Children's Hospital Research Institute Identifier: NCT00616395     History of Changes
Other Study ID Numbers: 07130
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

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