Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition

Undernutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239208
• Other study ID #: AL45
• Status: Completed
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: December 18, 2022

Study information

• Verified date: February 2023
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: December 18, 2022
• Est. primary completion date: December 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 60 Months

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

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

Locations

Country	Name	City	State
Vietnam	National Institute of Nutrition	Ha Noi

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Composition	Measured by duel-energy x-ray absorptiometry	Baseline to 240 Days
Other	Bone Quality	Measured by duel-energy x-ray absorptiometry	Baseline to 240 Days
Other	Lower Leg Length	Measured in cm	Baseline to 240 Days
Other	Adverse Event Reporting	Parent reported adverse events	Baseline to 240 Days
Other	Healthcare Utilization	Number of sick days, healthcare visits, missed days school, missed days work	Baseline to 240 Days
Other	Physical Activity	Visual analog scale Not Active to Very Active	Baseline to 240 Days
Other	Child's Healthy Growth	Parent completed assessment of child's growth	Baseline to 240 Days
Other	Product Palatability	1, 5-point scale from Dislike it very much to Like to very much	Study Day 1 to Study Day 240
Other	Child's Sleep Assessment	Parent reported sleep habits	Baseline to 240 Days
Other	Early Childhood Behavior Questionnaire	6, 7-point Likert scale questions scored from Never to Always	Baseline to 240 Days
Other	Blood Biomarkers Amino Acid	Blood chemistry analysis of amino acid biomarkers	Baseline to 240 Days
Other	Blood Biomarkers Bone	Blood chemistry analysis of bone biomarkers	Baseline to 240 Days
Other	Hand Grip Strength	Measured in kg	Baseline to 240 Days
Primary	Weight-for-Age Z-Score	Change in weight-for-age z-score	Baseline to 120 Days
Secondary	Weight	Measured in Kg	Baseline to 240 Days
Secondary	Height	Measured in cm	Baseline to 240 Days
Secondary	Mid-Upper-Arm Circumference (MUAC)	Measured in cm	Baseline to 240 Days
Secondary	Weight-for-Height Measurement Calculations	Weight-for-height standard z-scores and percentiles	Baseline to 240 Days
Secondary	BMI-for-Age Measurement Calculations	BMI-for-age standard z-scores and percentiles	Baseline to 240 Days
Secondary	Height-for-Age Measurement Calculations	Height-for-age standard z-scores and percentiles	Baseline to 240 Days
Secondary	MUAMC Measurement Calculations	Mid-upper-arm-circumference-for-age standard z-scores and percentiles	Baseline to 240 Days
Secondary	Dietary Intake	Measured by 24-hour dietary recall	Baseline to 240 Days
Secondary	Appetite	Visual analog scale from Ate Very Little to Ate Very Much	Baseline to 240 Days