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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05489094
Eligibility Criteria:
Inclusion Criteria:
* Apparently healthy Indonesian children
* Age 12 - 32 months at baseline visit
* Willing to take min 2 serving of study product per day
* Daily Iron intake less than 80% of Indonesian RDA (\<5.6 mg/day)
* Planning to reside in the study area during the next 4 months
* Written informed consent by parent(s) or legally acceptable representative (in ICF there is statement that both are agree that child participate in the study)
Exclusion Criteria:
* Having Hb \<8 g/dL using Hemocue
* Having cow's milk allergy, galactosemia, conditions needing a special diet, like major renal and hepatic dysfunction, major gastrointestinal intolerance (e.g., severe vomiting, severe diarrhea), investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements, participation in any other study within two weeks prior to entry into the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
32 Months
Study:
NCT05489094
Study Brief:
Protocol Section:
NCT05489094