Clinical trial NCT05239208: Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition
Official title: Effects of Oral Nutritional Supplementation With Dietary Counseling in 24-60 Months Old Children at Risk of Undernutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 330
Sex: ALL
Minimum age (years): 24
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Weight-for-Age Z-Score
timeFrame: Baseline to 120 Days
Secondary outcomes:
measure: Weight
timeFrame: Baseline to 240 Days
measure: Height
timeFrame: Baseline to 240 Days
measure: Mid-Upper-Arm Circumference (MUAC)
timeFrame: Baseline to 240 Days
measure: Weight-for-Height Measurement Calculations
timeFrame: Baseline to 240 Days
measure: BMI-for-Age Measurement Calculations
timeFrame: Baseline to 240 Days
measure: Height-for-Age Measurement Calculations
timeFrame: Baseline to 240 Days
measure: MUAMC Measurement Calculations
timeFrame: Baseline to 240 Days
measure: Dietary Intake
timeFrame: Baseline to 240 Days
measure: Appetite
timeFrame: Baseline to 240 Days
Other outcomes:
measure: Body Composition
timeFrame: Baseline to 240 Days
measure: Bone Quality
timeFrame: Baseline to 240 Days
measure: Lower Leg Length
timeFrame: Baseline to 240 Days
measure: Adverse Event Reporting
timeFrame: Baseline to 240 Days
measure: Healthcare Utilization
timeFrame: Baseline to 240 Days
measure: Physical Activity
timeFrame: Baseline to 240 Days
measure: Child's Healthy Growth
timeFrame: Baseline to 240 Days
measure: Product Palatability
timeFrame: Study Day 1 to Study Day 240
measure: Child's Sleep Assessment
timeFrame: Baseline to 240 Days
measure: Early Childhood Behavior Questionnaire
timeFrame: Baseline to 240 Days
measure: Blood Biomarkers Amino Acid
timeFrame: Baseline to 240 Days
measure: Blood Biomarkers Bone
timeFrame: Baseline to 240 Days
measure: Hand Grip Strength
timeFrame: Baseline to 240 Days
Locations:
city: Ha Noi
country: Vietnam
facility: National Institute of Nutrition
Study officials:
affiliation: Abbott
name: Yen Ling Mandy Ow, PhD
role: STUDY_CHAIR
References: