Oral Nutritional Supplementation in Children at Risk of Undernutrition

Undernutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05161000
• Other study ID #: AL48
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: Abbott Nutrition
• Contact: Kristen DeLuca, MS, RDN, LDN
• Phone: 614-624-5455
• Email: kristen.deluca[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Months to 107 Months

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

Other:
• Oral Nutritional Supplement
ONS plus dietary counseling
• Dietary counseling
dietary counseling

Locations

Country	Name	City	State
United States	Velocity Clinical Research	Covington	Louisiana
United States	Javara, Inc. 3377	Dallas	Texas
United States	Proactive Clinical Research	Edinburg	Texas
United States	HealthStar Research Glenwood	Glenwood	Arkansas
United States	Tribe Clinical Research LLC.	Greenville	South Carolina
United States	HealthStar Research, LLC	Hot Springs	Arkansas
United States	Gulf Bank Medical Center	Houston	Texas
United States	Kissimmee Clinical Research	Kissimmee	Florida
United States	Alivation Research (Primary Care)	Lincoln	Nebraska
United States	L.A. Universal Research Center, Inc.	Los Angeles	California
United States	D&H National Research Centers	Miami	Florida
United States	Dade Research Center, LLC	Miami	Florida
United States	Suncoast Research, Assoc., LLC	Miami	Florida
United States	Midway Medical Clinic	Oneonta	Alabama
United States	Springs Medical Research	Owensboro	Kentucky
United States	Chrysalis Clinical Research	Saint George	Utah
United States	Gentle Pediatrics	Sugar Land	Texas
United States	Javara Inc. 3380	Winston-Salem	North Carolina
United States	Southern Clinical Research	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hand Grip Strength	Measured in kg	baseline to 120 days
Other	Nutrition Biomarkers	Blood chemistry analysis of vitamin A, vitamin B12, vitamin D, vitamin E, folate, and vitamin K	baseline to 120 days
Other	Adverse Event Reporting	Standard adverse event reporting	baseline to 120 days
Other	Health Care Utilization	Number of unscheduled visits or missed school days (child) or work days (parent)	baseline to 120 days
Other	Sleep Data	Average daily number of hours	baseline to 120 days
Other	Activity Data	Average daily number of minutes	baseline to 120 days
Other	Physical Activity	Visual analog scale from Not Active to Very Active	baseline to 120 days
Other	Parental Stress Scale	18 questions scaled from Strongly disagree to Strongly Agree	baseline to 120 days
Other	Child Eating Behavior Questionnaire	35 questions 5-Point Likert Scale from Never to Always	baseline to 120 days
Other	Caregiver Opinion Questionnaire	3 Parent reported questions related to child's nutrition	baseline to 120 days
Other	Children's Sleep Habit Questionnaire	7 Parent reported questions related to child's sleep habits	baseline to 120 days
Other	Triceps Skinfold	Measured in mm	baseline to 120 days
Primary	Weight-for-age z-score (WAZ)	Change in weight-for-age z-score	baseline to 120 days
Secondary	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
Secondary	Mid-upper-arm circumference (MUAC)	Measured in cm	baseline to 120 days
Secondary	Weight	Measured in Kg	baseline to 120 days
Secondary	Height	Measured in cm	baseline to 120 days
Secondary	Dietary Diversity	Measured by 24-hour dietary recall	baseline to 120 days
Secondary	Appetite	Visual analog scale from Ate Very Little to Ate A Lot	baseline to 120 days