Beginnings: Study of Early Infant Diet on Growth and Development
Sponsor
Arkansas Children's Hospital Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00616395
Collaborator
(none)
600
1
243
2.5
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated 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
:
Sep 1, 2002
Actual Primary Completion Date
:
Sep 1, 2017
Anticipated Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| no grouping IDE used for outcome measurement not for an intervention. |
Device: No intervention
|
Outcome Measures
Primary Outcome Measures
- Growth and development [yearly, 1-6 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Month
to 3 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Children's Nutrition Center | Little Rock | Arkansas | United States | 72202 |
Sponsors and Collaborators
- Arkansas Children's Hospital Research Institute
Investigators
- Principal Investigator: Aline Andres, Ph.D., University of Arkansas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00616395
Other Study ID Numbers:
- 07130
First Posted:
Feb 15, 2008
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Keywords provided by Arkansas Children's Hospital Research Institute