Clinical trial NCT05161000: Oral Nutritional Supplementation in Children at Risk of Undernutrition
Official title: Effects of Oral Nutritional Supplementation With Dietary Counseling in Children at Risk of Undernutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 279
Sex: ALL
Minimum age (years): 36
Maximum age (years): 107
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight-for-age z-score (WAZ)
timeFrame: baseline to 120 days
Secondary outcomes:
measure: Anthropometric Measurement Calculations
timeFrame: baseline to 120 days
measure: Mid-upper-arm circumference (MUAC)
timeFrame: baseline to 120 days
measure: Weight
timeFrame: baseline to 120 days
measure: Height
timeFrame: baseline to 120 days
measure: Dietary Diversity
timeFrame: baseline to 120 days
measure: Appetite
timeFrame: baseline to 120 days
Other outcomes:
measure: Hand Grip Strength
timeFrame: baseline to 120 days
measure: Nutrition Biomarkers
timeFrame: baseline to 120 days
measure: Adverse Event Reporting
timeFrame: baseline to 120 days
measure: Health Care Utilization
timeFrame: baseline to 120 days
measure: Sleep Data
timeFrame: baseline to 120 days
measure: Activity Data
timeFrame: baseline to 120 days
measure: Physical Activity
timeFrame: baseline to 120 days
measure: Parental Stress Scale
timeFrame: baseline to 120 days
measure: Child Eating Behavior Questionnaire
timeFrame: baseline to 120 days
measure: Caregiver Opinion Questionnaire
timeFrame: baseline to 120 days
measure: Children's Sleep Habit Questionnaire
timeFrame: baseline to 120 days
measure: Triceps Skinfold
timeFrame: baseline to 120 days
Locations:
city: Oneonta
country: United States
facility: Midway Medical Clinic
state: Alabama
city: Glenwood
country: United States
facility: HealthStar Research Glenwood
state: Arkansas
city: Hot Springs
country: United States
facility: HealthStar Research, LLC
state: Arkansas
city: Los Angeles
country: United States
facility: L.A. Universal Research Center, Inc.
state: California
city: Kissimmee
country: United States
facility: Kissimmee Clinical Research
state: Florida
city: Miami
country: United States
facility: Dade Research Center, LLC
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers
state: Florida
city: Miami
country: United States
facility: Suncoast Research, Assoc., LLC
state: Florida
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Covington
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Zachary
country: United States
facility: Southern Clinical Research
state: Louisiana
city: Lincoln
country: United States
facility: Alivation Research (Primary Care)
state: Nebraska
city: Winston-Salem
country: United States
facility: Javara Inc. 3380
state: North Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research LLC.
state: South Carolina
city: Dallas
country: United States
facility: Javara, Inc. 3377
state: Texas
city: Edinburg
country: United States
facility: Proactive Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Gentle Pediatrics
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams, MPH
role: STUDY_CHAIR
References: