Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition

NCT ID: NCT05239208

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-14
• Study Completion Date: 2022-12-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Oral Nutritional Supplement (ONS) Group

Two servings per day in addition to dietary counseling

Group Type: EXPERIMENTAL

Oral Nutrition Supplement (ONS) Group

Intervention Type: OTHER

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

Control Group

Dietary counseling

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

Dietary counseling

Interventions

Oral Nutrition Supplement (ONS) Group

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

Intervention Type: OTHER

Control Group

Dietary counseling

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yen Ling Mandy Ow, PhD

Role: STUDY_CHAIR

Abbott

Locations

National Institute of Nutrition

Hà Nội, , Vietnam

Countries

Vietnam

References

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.

Reference Type: DERIVED

PMID: 40660276 (View on PubMed)

Other Identifiers

AL45

Identifier Type: -

Identifier Source: org_study_id