Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01263912
Eligibility Criteria:
Inclusion criteria:
* term gestation (37-41 weeks gestation and 2500g or more at birth)
* single birth
* English as the primary language in the home
* non-smoking home environment
* a healthy infant not yet 13 months-of-age, who is not currently breast-fed or fed infant formula with ARA and DHA.
* primary milk source is cows' milk, cows' milk substitutes, or other milk substitutes containing no supplemental fatty acids from enrollment to 24 months-of age.
* the infant has no known food allergies, metabolic, neurological, genetic, or immune disorders that are likely, in the opinion of the investigator to impact the outcome measures in this study.
* the infant has not been fatty acid or oil, including fish oil supplements and there is no intent to provide these supplements during the study.
* the infant has no history of hospitalization, growth failure or any other event which in the opinion of the investigator is likely to impact the outcome measures in this study.
Exclusion Criteria:
* any infant that does not meet the inclusion criteria will not be included in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
13 Months
Study:
NCT01263912
Study Brief:
Protocol Section:
NCT01263912