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:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT02668133
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent from at least one parent, including consent for samples to be shipped outside of The Gambia
* Age 18-23 months
* non-breast feeding children and consumption of coos porridge
* Previous consumption of peanut based products with no known adverse reaction
Exclusion Criteria:
* Weight-for-height z-score (WHZ) \<-3 Z with respect to WHO 2006 standards\*
* Presence of bipedal oedema
* Severe illness warranting hospital referral
* Congenital abnormalities potentially interfering with micronutrient metabolism
* Chronic medical condition (e.g. malignancy) requiring frequent medical attention
* Known HIV infection of index child or child's mother
* Currently consuming vitamin or mineral supplements or zinc- or iron-fortified infant formulas/foods
* Diarrhoea (\>3 liquid or semi-liquid stools per day) within the past 7 days
* Symptomatic acute or chronic febrile infection within the past 7 days
* Hemoglobin \< 70 g/L\*
* Positive rapid diagnostic test for malaria antigenemia (HRP2)\* \* Exclusion criteria for main metabolic study only (not criteria for the pilot feeding study, as anthropometric and biochemical data will not be collected
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
23 Months
Study:
NCT02668133
Study Brief:
Protocol Section:
NCT02668133