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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT02523027
Eligibility Criteria:
Inclusion Criteria:
1. Child is \> 24 months and ≤ 48 months of age at visit 1.
2. Child of either gender (Male and Female).
3. Child has a weight-for-height between 3rd - 15th percentiles according to current WHO Growth Charts at visit 1. (WHO Growth Chart 2007)
4. Child is a picky eater, defined as meeting at least two of the following criteria. A child, who:
* eats only a limited number of foods
* is unwilling to try new foods
* refuses to eat vegetables and/or foods from other food groups
* shows strong food likes and dislikes
* has behaviors that disrupt mealtime
5. Child is a habitual milk drinker at least 1 glass (approximately 200mL) of milk daily.
6. Child is able to consume foods and beverages orally.
7. Child's Legal Guardian (LG) or parent(s) is willing to abstain from giving additional non-study nutritional supplements including vitamin/mineral supplements, micronutrient fortified beverages, oral nutritional supplements other than the study product during the study intervention period.
8. Child's Legal Guardian (LG) or parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
9. Child's Legal Guardian (LG) or parent(s) is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
10. Child's Legal Guardian (LG) or parent(s)is not planning to relocate during the study period
Exclusion Criteria:
1. Child has been diagnosed with Lactose Intolerance \& Galactosemia according to medical records or Legal Guardian (LG) /parent report.
2. Child has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or Legal Guardian (LG)/parent report.
3. Child has a current acute or chronic infection including respiratory infection, diarrhea, acute or chronic, Hepatitis B or C, HIV infection or tuberculosis according to medical records or Legal Guardian (LG)/parent report.
4. Child has been diagnosed with presence of severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records or Legal Guardian (LG)/parent report.
5. Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or Legal Guardian (LG) /parent report.
6. Child has been diagnosed with hormonal or metabolic disorders according to medical records or Legal Guardian (LG) /parent report.
7. Child has been diagnosed with congenital disease or genetic disorders such as atrial or ventricular wall defects, or Down's syndrome according to medical records or Legal Guardian (LG) /parent report.
8. Child has been diagnosed with infantile anorexia nervosa according to medical records or Legal Guardian (LG) /parent report.
9. Child has been diagnosed with a developmental disability, including physical disorders such as cerebral palsy, or developmental delay according to medical records or Legal Guardian (LG) /parent report.
10. Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or Legal Guardian (LG) /parent report.
11. Child has a clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
12. Child has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
4 Years
Study:
NCT02523027
Study Brief:
Protocol Section:
NCT02523027