Oral Nutritional Supplementation in Children at Risk of Undernutrition

July 14, 2024 updated by: Abbott Nutrition

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
279

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight-for-age z-score (WAZ)
Time Frame: baseline to 120 days
Change in weight-for-age z-score
baseline to 120 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anthropometric Measurement Calculations
Time Frame: baseline to 120 days
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)
Time Frame: baseline to 120 days
Measured in cm
baseline to 120 days
Weight
Time Frame: baseline to 120 days
Measured in Kg
baseline to 120 days
Height
Time Frame: baseline to 120 days
Measured in cm
baseline to 120 days
Dietary Diversity
Time Frame: baseline to 120 days
Measured by 24-hour dietary recall
baseline to 120 days
Appetite
Time Frame: baseline to 120 days
Visual analog scale from Ate Very Little to Ate A Lot
baseline to 120 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hand Grip Strength
Time Frame: baseline to 120 days
Measured in kg
baseline to 120 days
Nutrition Biomarkers
Time Frame: baseline to 120 days
Blood chemistry analysis of vitamin A, vitamin B12, vitamin D, vitamin E, folate, and vitamin K
baseline to 120 days
Adverse Event Reporting
Time Frame: baseline to 120 days
Standard adverse event reporting
baseline to 120 days
Health Care Utilization
Time Frame: baseline to 120 days
Number of unscheduled visits or missed school days (child) or work days (parent)
baseline to 120 days
Sleep Data
Time Frame: baseline to 120 days
Average daily number of hours
baseline to 120 days
Activity Data
Time Frame: baseline to 120 days
Average daily number of minutes
baseline to 120 days
Physical Activity
Time Frame: baseline to 120 days
Visual analog scale from Not Active to Very Active
baseline to 120 days
Parental Stress Scale
Time Frame: baseline to 120 days
18 questions scaled from Strongly disagree to Strongly Agree
baseline to 120 days
Child Eating Behavior Questionnaire
Time Frame: baseline to 120 days
35 questions 5-Point Likert Scale from Never to Always
baseline to 120 days
Caregiver Opinion Questionnaire
Time Frame: baseline to 120 days
3 Parent reported questions related to child's nutrition
baseline to 120 days
Children's Sleep Habit Questionnaire
Time Frame: baseline to 120 days
7 Parent reported questions related to child's sleep habits
baseline to 120 days
Triceps Skinfold
Time Frame: baseline to 120 days
Measured in mm
baseline to 120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jennifer Williams, MPH, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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