Study of Early Infant Diet on Growth and Development (Beginnings)
This study is ongoing, but not recruiting participants.
Sponsor:
Arkansas Children's Hospital Research Institute
Collaborators:
USDA Beltsville Human Nutrition Research Center
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00616395
First received: December 31, 2007
Last updated: January 28, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Healthy |
Device: No intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children |
Further study details as provided by Arkansas Children's Hospital Research Institute:
Primary Outcome Measures:
- Growth and development [ Time Frame: yearly, 1-6 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Plasma and urine may be collected from some study participants.
| Estimated Enrollment: | 600 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
no grouping
IDE used for outcome measurement not for an intervention.
|
Device: No intervention |
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
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616395
Locations
| United States, Arkansas | |
| Arkansas Children's Nutrition Center | |
| Little Rock, Arkansas, United States, 72202 | |
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
USDA Beltsville Human Nutrition Research Center
University of Arkansas
Investigators
| Principal Investigator: | Aline Andres, Ph.D. | University of Arkansas |
More Information
No publications provided
| Responsible Party: | Arkansas Children's Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00616395 History of Changes |
| Other Study ID Numbers: | 07130 |
| Study First Received: | December 31, 2007 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Arkansas Children's Hospital Research Institute:
|
Infant Nutrition Soy Phytochemicals Infant Body Composition |
Brain Function Cognition and Development Healthy Infants |
ClinicalTrials.gov processed this record on May 23, 2013