Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition

Not Applicable

Completed

• Conditions: Undernutrition

• Registration Number: NCT05239208
• Lead Sponsor: Abbott Nutrition

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-07
• Study Start: 2022-01-14
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-14
• Primary Completion: 2022-12-18
• Study Completion: 2022-12-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-26
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight-for-Age Z-Score	Baseline to 120 Days	Change in weight-for-age z-score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Institute of Nutrition; 🇻🇳 Ha Noi, Vietnam