Nutritional Supplementation in Children at Risk of Undernutrition

Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition

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.

Study Overview

• Status: Withdrawn
• Conditions: Malnutrition, Child
• Intervention / Treatment: Other: Oral Nutritional Supplement (ONS)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn University
  • Bangkok, Thailand, 10400
    • Queen Sirikit National Institute of Child Health
  • Bangkok, Thailand, 10400
    • Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Nutritional Supplement (ONS) Group; Two servings per day in addition to dietary counseling	Other: Oral Nutritional Supplement (ONS); ONS plus dietary counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height-for-age-Z-score	Change in Height-for-age-Z-score	Baseline to 120 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Evaluation of Child's Healthy Growth	Parent-reported satisfaction and assessment of child's healthy growth on 10-point visual analog scale, scored from 0 Very dissatisfied/Strongly disagree to 10 Very satisfied/Strongly agree, with higher scores being favorable	Baseline to 30 days and 120 days
Parental Assessment of Child's Sleep	Parent-reported questionnaire of child's usual amount of sleep (hours and minutes), and number (number of times) and length (minutes) of awakenings per night	Baseline to 30 days and 120 days
Adverse Event	Number of participants with reported adverse events	Baseline to 120 days
Illness Questionnaire	Parent reported number of sick episodes, sick days, healthcare visits and symptoms, with higher number reported being less favorable	Baseline to 120 days
Mid Upper Arm Muscle Circumference (MUAMC) Calculation	Changes in MUAMC calculations	Baseline to 30 days and 120 days
Arm Muscle Area (AMA) Calculation	Changes in AMA calculations	Baseline to 30 days and 120 days
Arm Fat Area (AFA) Calculation	Changes in AFA calculations	Baseline to 30 days and 120 days
Arm Fat Index (AFI) Calculation	Changes in AFI calculations	Baseline to 30 days and 120 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Yen Ling Mandy Ow, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• Other Study ID Numbers: AL55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No