Oral Nutritional Supplementation in Children at Risk of Undernutrition

Effects of Oral Nutritional Supplementation With Dietary Counseling in Children at Risk of Undernutrition

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.

Study Overview

• Status: Completed
• Conditions: Undernutrition
• Intervention / Treatment: Other: Oral Nutritional Supplement; Other: Dietary counseling

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Oneonta, Alabama, United States, 35121
      • Midway Medical Clinic
  • Arkansas
    • Glenwood, Arkansas, United States, 71943
      • HealthStar Research Glenwood
    • Hot Springs, Arkansas, United States, 71913
      • HealthStar Research, LLC
  • California
    • Los Angeles, California, United States, 90057
      • L.A. Universal Research Center, Inc.
  • Florida
    • Kissimmee, Florida, United States, 34743
      • Kissimmee Clinical Research
    • Miami, Florida, United States, 33155
      • D&H National Research Centers
    • Miami, Florida, United States, 33126
      • Dade Research Center, LLC
    • Miami, Florida, United States, 33173
      • Suncoast Research, Assoc., LLC
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Velocity Clinical Research
    • Zachary, Louisiana, United States, 70791
      • Southern Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research (Primary Care)
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Javara Inc. 3380
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research LLC.
  • Texas
    • Dallas, Texas, United States, 75230
      • Javara, Inc. 3377
    • Edinburg, Texas, United States, 78539
      • Proactive Clinical Research
    • Sugar Land, Texas, United States, 77479
      • Gentle Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Nutritional Supplement (ONS) Group; Two servings per day in addition to dietary counseling	Other: Oral Nutritional Supplement; ONS plus dietary counseling; Other: Dietary counseling; dietary counseling
Other: Control Group; dietary counseling	Other: Dietary counseling; dietary counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight-for-age z-score (WAZ)	Change in weight-for-age z-score	baseline to 120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric Measurement Calculations	Standard z-scores and percentiles including weight-for-age, height-for-age, weight-for-height, BMI-for-age and mid-upper-arm-circumference-for-age	baseline to 120 days
Mid-upper-arm circumference (MUAC)	Measured in cm	baseline to 120 days
Weight	Measured in Kg	baseline to 120 days
Height	Measured in cm	baseline to 120 days
Dietary Diversity	Measured by 24-hour dietary recall	baseline to 120 days
Appetite	Visual analog scale from Ate Very Little to Ate A Lot	baseline to 120 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Grip Strength	Measured in kg	baseline to 120 days
Nutrition Biomarkers	Blood chemistry analysis of vitamin A, vitamin B12, vitamin D, vitamin E, folate, and vitamin K	baseline to 120 days
Adverse Event Reporting	Standard adverse event reporting	baseline to 120 days
Health Care Utilization	Number of unscheduled visits or missed school days (child) or work days (parent)	baseline to 120 days
Sleep Data	Average daily number of hours	baseline to 120 days
Activity Data	Average daily number of minutes	baseline to 120 days
Physical Activity	Visual analog scale from Not Active to Very Active	baseline to 120 days
Parental Stress Scale	18 questions scaled from Strongly disagree to Strongly Agree	baseline to 120 days
Child Eating Behavior Questionnaire	35 questions 5-Point Likert Scale from Never to Always	baseline to 120 days
Caregiver Opinion Questionnaire	3 Parent reported questions related to child's nutrition	baseline to 120 days
Children's Sleep Habit Questionnaire	7 Parent reported questions related to child's sleep habits	baseline to 120 days
Triceps Skinfold	Measured in mm	baseline to 120 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Jennifer Williams, MPH, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 14, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: AL48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No