Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition

NCT05239208 | Completed

• 1 other identifier: AL45
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Undernutrition

Outcome Measures

Primary Outcomes (1)

• Weight-for-Age Z-Score

  Change in weight-for-age z-score

  Baseline to 120 Days

Secondary Outcomes (9)

• Weight

  Baseline to 240 Days

• Height

  Baseline to 240 Days

• Mid-Upper-Arm Circumference (MUAC)

  Baseline to 240 Days

• Weight-for-Height Measurement Calculations

  Baseline to 240 Days

• BMI-for-Age Measurement Calculations

  Baseline to 240 Days

Other Outcomes (13)

• Body Composition

  Baseline to 240 Days

• Bone Quality

  Baseline to 240 Days

• Lower Leg Length

  Baseline to 240 Days

Study Arms (2)

Oral Nutritional Supplement (ONS) Group

EXPERIMENTAL

Two servings per day in addition to dietary counseling

Other: Oral Nutrition Supplement (ONS) Group

Control Group

ACTIVE COMPARATOR

Dietary counseling

Other: Control Group

Interventions

Oral Nutrition Supplement (ONS) Group OTHER

Oral nutritional supplement specifically designed for nutritionally-at risk children and dietary counseling

Oral Nutritional Supplement (ONS) Group

Control Group OTHER

Dietary counseling

Control Group

Eligibility Criteria

• Age: 24 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic (Exception: Intestinal parasites infection)
• 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) as diagnosed by the investigator.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

National Institute of Nutrition

Hà Nội, 11611, Vietnam

Location

Related Publications (1)

• Ow MYL, Tran NT, Berde Y, Nguyen TS, Tran VK, Jablonka MJ, Baggs GE, Huynh DTT. Efficacy of long-term oral nutritional supplementation with dietary counseling on growth, body composition and bone mineralization in children with or at risk for undernutrition: a randomized controlled trial. Nutr J. 2025 Jul 14;24(1):110. doi: 10.1186/s12937-025-01133-5.

  PMID: 40660276 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Population Groups; Control Groups

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yen Ling Mandy Ow, PhD

  Abbott

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 14, 2022
• Study Start: January 14, 2022
• Primary Completion: December 18, 2022
• Study Completion: December 18, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)