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:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT03996395
Eligibility Criteria:
Inclusion Criteria:
* 4-4.5 months old at baseline
* born at term (\>/=37 weeks gestation)
* within the 5th-95th weight-for-age percentile (inclusive)
* primary caregiver can speak, read, and understand English
* infants are exclusively breast- and/or formula-feeding at baseline
* consenting parent or caregiver must be 18 years old or older
Exclusion Criteria:
* has a sibling enrolled in the study
* metabolic, digestive, or malabsorptive disorders
* known bleeding or clotting disorder
* requires a special diet
* exposed to tobacco smoke in the home
* currently taking any isolated carotenoid supplements
* using medications or complementary or alternative medications that interfere with dietary fat absorption
* has a history of endocrine disorders requiring hormone administration.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Months
Maximum Age:
9 Months
Study:
NCT03996395
Study Brief:
Protocol Section:
NCT03996395