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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT01658267
Eligibility Criteria:
Inclusion Criteria:
* Child is between 36 and 48 months of age.
* Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile.
* Child is capable of oral feeding.
* Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period.
Exclusion Criteria:
* Child whose either parent has BMI greater than or equal to 27.5 kg/m2.
* Child allergic or intolerant to any ingredient found in the study product.
* Child who was delivered pre-term.
* Child was born small for gestational
* Child had birth weight \< 2500 g or \> 4000 g.
* Child has current acute or chronic infections.
* Child demonstrates presence of severe gastrointestinal disorders.
* Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases.
* Child has a diagnosis of hormonal or metabolic disorders.
* Child has a congenital disease or genetic disorder.
* Child is diagnosed with infantile anorexia nervosa.
* Child has a developmental disability or physical disorder.
* Child has disorders of hemoglobin structure, function or synthesis.
* Child is participating in another study that has not been approved as a concomitant study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
36 Months
Maximum Age:
48 Months
Study:
NCT01658267
Study Brief:
Protocol Section:
NCT01658267