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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT03894358
Eligibility Criteria:
Inclusion Criteria:
* 6 to 11 months at baseline
* Anticipated residence in study area for the study duration
* In good health as assessed by professional staff at Msambweni County Referral hospital
* Caregiver is willing to participate and able to comply with study procedures
* Informed consent form has been read and signed by the caregiver (or has been read out to the caregiver)
Exclusion Criteria:
* Hemoglobin concentration less than 70 g/L
* Severe underweight (Z-score weight-for-age \<-3)
* Severe wasting (Z-score weight-for-height \<-3
* Chronic or acute illness or other conditions that in the opinion of the Principal Investigator (PI) or study pediatrician would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
* Participant taking part in other studies requiring the drawing of blood
* Regular intake (\>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months
* Antibiotic treatment in the past 4 weeks prior to study enrollment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
11 Months
Study:
NCT03894358
Study Brief:
Protocol Section:
NCT03894358