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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT03993860
Eligibility Criteria:
Inclusion Criteria:
* Infants aged 6 months attending under-five clinic at the sampled RHC. Infants should ideally be 6 months of age however, the study will provide leeway of 2 weeks, and therefore infants falling within the age range 5.5 - 6.5 months may be included. If a 5.5-month-old infant has however not been started with complementary food, the mother will be advised to only start at the age of 6 months with the product.
* Infants whose mothers give written consent
* Infants whose mothers have no plans of moving away during the study period
Exclusion Criteria:
* Infants with, chronic or congenital diseases/disorders that may affect the growth of the children. These may include Down syndrome, cerebral palsy, spina bifida and any other related condition.
* Premature infants
* infected infants
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
6 Months
Study:
NCT03993860
Study Brief:
Protocol Section:
NCT03993860