Nutritional Supplementation in Children at Risk of Undernutrition

Not Applicable

Withdrawn

• Conditions: Malnutrition, Child
• Interventions: Other: Oral Nutritional Supplement (ONS)

• Registration Number: NCT05437068
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Study Start: 2022-11-11
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Nutritional Supplement (ONS) Group	Oral Nutritional Supplement (ONS)	Two servings per day in addition to dietary counseling

Primary Outcome Measures

Name	Time	Method
Height-for-age-Z-score	Baseline to 120 days	Change in Height-for-age-Z-score

Secondary Outcome Measures

Name	Time	Method
BMI-for-Age Measurement Calculations	Baseline to 30 days and 120 days	BMI-for-age standard z scores and percentiles
Weight	Baseline to 30 days and 120 days	Measured in Kg
Dietary Intake	Baseline to 30 days and 120 days	Measured by 24-hour dietary recall
Appetite	Baseline to 30 days and 120 days	Visual analog scale from 0 (Ate Very Little) to 10 (Ate Very Much) with high scores being favorable
Weight-for-Height Measurement Calculations	Baseline to 30 days and 120 days	Weight-for-height standard z scores and percentiles
Physical Activity	Baseline to 30 days and120 days	Visual analog scale from 0 (Not Active) to 10 (Very Active) with high scores being favorable
Weight-for-Age Measurement Calculations	Baseline to 30 days and 120 days	Weight-for-age standard z scores and percentiles
Height-for-Age Measurement Calculations	Baseline to 30 days and 120 days	Height-for-age standard z scores and percentiles
Height	Baseline to 30 days and 120 days	Measured in cm
Mid-Upper-Arm Circumference (MUAC)	Baseline to 30 days and 120 days	Measured in cm
MUAC-for-Age Measurement Calculations	Baseline to 30 days and 120 days	MUAC-for-age standard z scores and percentiles