Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition

Effects of Oral Nutritional Supplementation With Dietary Counseling in 24-60 Months Old Children at Risk of Undernutrition

This prospective, randomized, controlled study will evaluate the effects of oral nutritional supplementation plus dietary counseling versus dietary counseling alone in children at nutritional risk.

Study Overview

• Status: Completed
• Conditions: Undernutrition
• Intervention / Treatment: Other: Oral Nutrition Supplement (ONS) Group; Other: Control Group

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ha Noi, Vietnam, 11611
    • National Institute of Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children 24-60 months old
• Undernourished or at risk of undernutrition according to the WHO Growth Standards.
• Child's parent(s)/legal guardian (LG) is willing to abstain from giving additional non-study ONS other than the study product during the study intervention period.
• 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:

• Participant 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 is currently drinking an Abbott product(s).
• 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 continuous oral nutrition supplement (ONS) usage for at least 15 days in the past 1 month prior to screening. The standard ONS formula usually has an energy density of at least 1 kcal/mL, containing protein, carbohydrate and/or fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition.
• 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 according to medical records or report by parent(s)/LG or the clinician's judgment:

  1. Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic (Exception: Intestinal parasites infection)
  2. 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
  3. Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay
  4. Disorders of hemoglobin structure, function or synthesis
  5. Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
  6. 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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 Nutrition Supplement (ONS) Group; Oral nutritional supplement specifically designed for nutritionally-at risk children and dietary counseling
Active Comparator: Control Group; Dietary counseling	Other: Control Group; Dietary counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight-for-Age Z-Score	Change in weight-for-age z-score	Baseline to 120 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Measured in Kg	Baseline to 240 Days
Height	Measured in cm	Baseline to 240 Days
Mid-Upper-Arm Circumference (MUAC)	Measured in cm	Baseline to 240 Days
Weight-for-Height Measurement Calculations	Weight-for-height standard z-scores and percentiles	Baseline to 240 Days
BMI-for-Age Measurement Calculations	BMI-for-age standard z-scores and percentiles	Baseline to 240 Days
Height-for-Age Measurement Calculations	Height-for-age standard z-scores and percentiles	Baseline to 240 Days
MUAMC Measurement Calculations	Mid-upper-arm-circumference-for-age standard z-scores and percentiles	Baseline to 240 Days
Dietary Intake	Measured by 24-hour dietary recall	Baseline to 240 Days
Appetite	Visual analog scale from Ate Very Little to Ate Very Much	Baseline to 240 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition	Measured by duel-energy x-ray absorptiometry	Baseline to 240 Days
Bone Quality	Measured by duel-energy x-ray absorptiometry	Baseline to 240 Days
Lower Leg Length	Measured in cm	Baseline to 240 Days
Adverse Event Reporting	Parent reported adverse events	Baseline to 240 Days
Healthcare Utilization	Number of sick days, healthcare visits, missed days school, missed days work	Baseline to 240 Days
Physical Activity	Visual analog scale Not Active to Very Active	Baseline to 240 Days
Child's Healthy Growth	Parent completed assessment of child's growth	Baseline to 240 Days
Product Palatability	1, 5-point scale from Dislike it very much to Like to very much	Study Day 1 to Study Day 240
Child's Sleep Assessment	Parent reported sleep habits	Baseline to 240 Days
Early Childhood Behavior Questionnaire	6, 7-point Likert scale questions scored from Never to Always	Baseline to 240 Days
Blood Biomarkers Amino Acid	Blood chemistry analysis of amino acid biomarkers	Baseline to 240 Days
Blood Biomarkers Bone	Blood chemistry analysis of bone biomarkers	Baseline to 240 Days
Hand Grip Strength	Measured in kg	Baseline to 240 Days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): December 18, 2022
• Study Completion (Actual): December 18, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 26, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: AL45

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