Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition

Abbott

Status: Completed

Conditions: Undernutrition

Treatments: Other: Oral Nutrition Supplement (ONS) Group; Other: Control Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT05239208

AL45

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 24 to 60 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 2 patient groups

Oral Nutritional Supplement (ONS) Group

Experimental group

Description:

Two servings per day in addition to dietary counseling

Treatment:

Other: Oral Nutrition Supplement (ONS) Group

Control Group

Active Comparator group

Description:

Dietary counseling

Treatment:

Other: Control Group