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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT05437068
Eligibility Criteria:
Inclusion Criteria:
Child is between 1 year 0 days to 5 years 364 days old at enrolment
Undernourished or at risk of undernutrition, defined as:
* WHZ \<- 1 and HAZ \<-1 for children up to 4 years 364 days, according to the WHO Growth Standards; or
* BMIAZ \<-1 and HAZ \<-1 for children 5 years 0 days and older, according to the WHO Growth Reference Standards
Child is not currently breastfed
Child's parent(s)/LG is willing to abstain from giving additional non-study Oral Nutritional Supplement (ONS) other than the study product during the study intervention period
Child is a singleton
Child's parent(s)/LG is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study
Child's parent(s)/LG is not planning to relocate during the study period
Child's parent(s)/LG has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study
Exclusion Criteria:
Child participates in another study that has not been approved as a concomitant study
Child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product
Child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG
Child had birth weight \< 2500 g or \> 4000 g
Child whose either parent has BMI ≥ 27.5 kg/m2
Child has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic Hepatitis B or C, HIV infection or tuberculosis
Child has been diagnosed with the following:
* Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
* Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, Down's syndrome, or thalassemia
* Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay
* Disorders of hemoglobin structure, function or synthesis
Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product)
Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
5 Years
Study:
NCT05437068
Study Brief:
Protocol Section:
NCT05437068