Oral Nutritional Supplementation in Children at Risk of Undernutrition

Abbott

Status: Completed

Conditions: Undernutrition

Treatments: Other: Oral Nutritional Supplement; Other: Dietary counseling

Study type: Interventional

Funder types: Industry

Identifiers

NCT05161000

AL48

Details and patient eligibility

About

The objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United States.

Enrollment: 279 patients

Sex: All

Ages: 36 to 107 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Child is 36 months - 107 months of age.
• Child is undernourished as determined by BMI for age z-score or Mid-upper-arm circumference z-score
• Child's caregiver has voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided Health Insurance Portability and Accountability Act (HIPAA) or other applicable privacy regulation authorization prior to any participation in the study.
• Child's caregiver is willing to abstain from providing non-study oral nutrition supplements during the study period duration.
• Child's caregiver is able and willing to follow study procedures and record data in parent diaries and complete any forms or assessments needed during the study.
• Child is willing to consume the study product for the duration of the study, if randomized to intervention group

Exclusion criteria

• Child has a height-for-age z-score ≥ 0.

• Child is currently drinking an oral nutritional supplement (ONS) on a regular basis (≥ 15 days in the past month)

• Child is participating in another study that has not been approved as a concomitant study by AN.

• Child has been diagnosed with the following:

  • Galactosemia, or an allergy or intolerance to any ingredient found in the study product
  • Acute or chronic infections including but not restricted to respiratory infections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis
  • Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
  • Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, Down's syndrome or significant, uncorrected cardiac anomalies that may impact growth
  • Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or a developmental delay that is considered too severe for participation
  • Disorders of hemoglobin structure, function or synthesis
  • Clinically significant nutritional deficiency requiring specialty nutritional therapy
  • Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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279 participants in 2 patient groups

Oral Nutritional Supplement (ONS) Group

Experimental group

Description:

Two servings per day in addition to dietary counseling

Treatment:

Other: Dietary counseling

Other: Oral Nutritional Supplement

Control Group

Other group

Description:

dietary counseling

Treatment:

Other: Dietary counseling