Status:
WITHDRAWN
Nutritional Supplementation in Children at Risk of Undernutrition
Lead Sponsor:
Abbott Nutrition
Conditions:
Malnutrition, Child
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05437068
Start Date
November 11 2022
End Date
November 11 2022
Last Update
March 1 2023
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