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 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT01789866
Eligibility Criteria:
Inclusion Criteria:
* full-term
* single birth (no multiple births)
* no major illness or surgery requiring hospitalization likely to impact the outcomes
* no metabolic, congenital or allergic disease that impact food intakes
* parents have sufficient command of English language to complete the informed consent and study documents
The specific inclusion enrollment criteria for:
Group 1: children consuming \<25 mg/day DHA and \< 400 μg/day lutein, n=24; Group 2: children consuming \>150 mg/day DHA and \>1,200 μg/day lutein, n=24; Group 3: children consuming \>150 mg/day DHA and \<400 μg/day lutein, n=10;
Exclusion Criteria:
* children of mothers enrolled in studies by our group that involved randomization to supplemental DHA during pregnancy
* children for whom blood, diet records or developmental tests at 5 years and 9 months of age are incomplete
* children consuming 25-150 mg/day DHA or 400-1200 μg/day lutein
* children of mothers who do not sign the informed consent
* any children having a cardiac pacemaker, aneurysm clip, cochlear implant of possible metallic foreign bodies in the eyes or other contraindication as detailed in the C\&W MRI Patient Screening Form will be excluded from this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
69 Months
Maximum Age:
78 Months
Study:
NCT01789866
Study Brief:
Protocol Section:
NCT01789866