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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT05440604
Eligibility Criteria:
Inclusion Criteria:
1. Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
2. Child's parent(s)/guardian is/are of legal age of consent, must understand the informed consent and other study documents, and is/are willing and able to fulfill the requirements of the study protocol
3. Age 3 years old to 4 years old and 6 months at enrolment
4. Healthy at birth, singleton, full-term gestational birth (37-42 completed weeks of gestation), with a birth weight of 2.5 kg to 3.9 kg
5. At the time of enrolment, the participant's weight-for-age, height-for-age, weight-for-height, BMI z-score should be within -2 to +1
6. At the time of enrolment, the participant is in good health (no history of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the child to ingest food, the normal growth and development of the child, or the evaluation of the infant; acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot \& mouth disease at time of enrolment is permitted) as determined by physical history, physical exam and judgement by the investigator
7. Child's parent(s)/guardian can be contacted directly by telephone or mobile phone throughout the study
Exclusion Criteria:
1. Chronic infectious, metabolic, genetic illness, or other disease including any condition that impacts feeding, or any outcome measures
2. Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin \< 100 g/L based on screening assessment, rickets based on physical exam).
3. Known or suspected cows' milk protein intolerance / lactose intolerance /allergy or severe food allergies that impact diet
4. Breast milk used exclusively / mixed in place of all other milk, and/or milk alternatives at 3 years of age
5. Consuming supplement(s) of relevance to the study outcome relating diet to status, vitamins A, D, E and C; zinc
6. Child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
36 Months
Maximum Age:
54 Months
Study:
NCT05440604
Study Brief:
Protocol Section:
NCT05440604