Clinical trial NCT05437068: Nutritional Supplementation in Children at Risk of Undernutrition
Official title: Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malnutrition, Child
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.


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

Primary outcomes:
measure: Height-for-age-Z-score
timeFrame: Baseline to 120 days
Secondary outcomes:
measure: Weight
timeFrame: Baseline to 30 days and 120 days
measure: Height
timeFrame: Baseline to 30 days and 120 days
measure: Mid-Upper-Arm Circumference (MUAC)
timeFrame: Baseline to 30 days and 120 days
measure: Weight-for-Height Measurement Calculations
timeFrame: Baseline to 30 days and 120 days
measure: Weight-for-Age Measurement Calculations
timeFrame: Baseline to 30 days and 120 days
measure: BMI-for-Age Measurement Calculations
timeFrame: Baseline to 30 days and 120 days
measure: Height-for-Age Measurement Calculations
timeFrame: Baseline to 30 days and 120 days
measure: MUAC-for-Age Measurement Calculations
timeFrame: Baseline to 30 days and 120 days
measure: Dietary Intake
timeFrame: Baseline to 30 days and 120 days
measure: Appetite
timeFrame: Baseline to 30 days and 120 days
measure: Physical Activity
timeFrame: Baseline to 30 days and120 days
Other outcomes:
measure: Parental Evaluation of Child's Healthy Growth
timeFrame: Baseline to 30 days and 120 days
measure: Parental Assessment of Child's Sleep
timeFrame: Baseline to 30 days and 120 days
measure: Adverse Event
timeFrame: Baseline to 120 days
measure: Illness Questionnaire
timeFrame: Baseline to 120 days
measure: Mid Upper Arm Muscle Circumference (MUAMC) Calculation
timeFrame: Baseline to 30 days and 120 days
measure: Arm Muscle Area (AMA) Calculation
timeFrame: Baseline to 30 days and 120 days
measure: Arm Fat Area (AFA) Calculation
timeFrame: Baseline to 30 days and 120 days
measure: Arm Fat Index (AFI) Calculation
timeFrame: Baseline to 30 days and 120 days
Locations:
Study officials:
affiliation: Abbott Nutrition
name: Yen Ling Mandy Ow, PhD
role: STUDY_CHAIR
References: