Back to resultsNutritional Supplementation in Children at Risk of Undernutrition
Primary Purpose
Malnutrition, Child
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral Nutritional Supplement (ONS)
Sponsored by
About this trial
This is an interventional other trial for Malnutrition, Child
Eligibility Criteria
Inclusion Criteria:
Child is between 1 year 0 days to 5 years 364 days old at enrolment
Undernourished or at risk of undernutrition, defined as:
- WHZ <- 1 and HAZ <-1 for children up to 4 years 364 days, according to the WHO Growth Standards; or
- BMIAZ <-1 and HAZ <-1 for children 5 years 0 days and older, according to the WHO Growth Reference Standards
Child is not currently breastfed
Child's parent(s)/LG is willing to abstain from giving additional non-study Oral Nutritional Supplement (ONS) other than the study product during the study intervention period
Child is a singleton
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:
Child 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 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 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:
- Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
- 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
- Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay
- Disorders of hemoglobin structure, function or synthesis
Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product)
Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oral Nutritional Supplement (ONS) Group
Arm Description
Two servings per day in addition to dietary counseling
Outcomes
Primary Outcome Measures
Height-for-age-Z-score
Change in Height-for-age-Z-score
Secondary Outcome Measures
Weight
Measured in Kg
Height
Measured in cm
Mid-Upper-Arm Circumference (MUAC)
Measured in cm
Weight-for-Height Measurement Calculations
Weight-for-height standard z scores and percentiles
Weight-for-Age Measurement Calculations
Weight-for-age standard z scores and percentiles
BMI-for-Age Measurement Calculations
BMI-for-age standard z scores and percentiles
Height-for-Age Measurement Calculations
Height-for-age standard z scores and percentiles
MUAC-for-Age Measurement Calculations
MUAC-for-age standard z scores and percentiles
Dietary Intake
Measured by 24-hour dietary recall
Appetite
Visual analog scale from 0 (Ate Very Little) to 10 (Ate Very Much) with high scores being favorable
Physical Activity
Visual analog scale from 0 (Not Active) to 10 (Very Active) with high scores being favorable
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05437068
Brief Title
Nutritional Supplementation in Children at Risk of Undernutrition
Official Title
Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Change in research focus
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Nutritional Supplement (ONS) Group
Arm Type
Experimental
Arm Description
Two servings per day in addition to dietary counseling
Intervention Type
Other
Intervention Name(s)
Oral Nutritional Supplement (ONS)
Intervention Description
ONS plus dietary counseling
Primary Outcome Measure Information:
Title
Height-for-age-Z-score
Description
Change in Height-for-age-Z-score
Time Frame
Baseline to 120 days
Secondary Outcome Measure Information:
Title
Weight
Description
Measured in Kg
Time Frame
Baseline to 30 days and 120 days
Title
Height
Description
Measured in cm
Time Frame
Baseline to 30 days and 120 days
Title
Mid-Upper-Arm Circumference (MUAC)
Description
Measured in cm
Time Frame
Baseline to 30 days and 120 days
Title
Weight-for-Height Measurement Calculations
Description
Weight-for-height standard z scores and percentiles
Time Frame
Baseline to 30 days and 120 days
Title
Weight-for-Age Measurement Calculations
Description
Weight-for-age standard z scores and percentiles
Time Frame
Baseline to 30 days and 120 days
Title
BMI-for-Age Measurement Calculations
Description
BMI-for-age standard z scores and percentiles
Time Frame
Baseline to 30 days and 120 days
Title
Height-for-Age Measurement Calculations
Description
Height-for-age standard z scores and percentiles
Time Frame
Baseline to 30 days and 120 days
Title
MUAC-for-Age Measurement Calculations
Description
MUAC-for-age standard z scores and percentiles
Time Frame
Baseline to 30 days and 120 days
Title
Dietary Intake
Description
Measured by 24-hour dietary recall
Time Frame
Baseline to 30 days and 120 days
Title
Appetite
Description
Visual analog scale from 0 (Ate Very Little) to 10 (Ate Very Much) with high scores being favorable
Time Frame
Baseline to 30 days and 120 days
Title
Physical Activity
Description
Visual analog scale from 0 (Not Active) to 10 (Very Active) with high scores being favorable
Time Frame
Baseline to 30 days and120 days
Other Pre-specified Outcome Measures:
Title
Parental Evaluation of Child's Healthy Growth
Description
Parent-reported satisfaction and assessment of child's healthy growth on 10-point visual analog scale, scored from 0 Very dissatisfied/Strongly disagree to 10 Very satisfied/Strongly agree, with higher scores being favorable
Time Frame
Baseline to 30 days and 120 days
Title
Parental Assessment of Child's Sleep
Description
Parent-reported questionnaire of child's usual amount of sleep (hours and minutes), and number (number of times) and length (minutes) of awakenings per night
Time Frame
Baseline to 30 days and 120 days
Title
Adverse Event
Description
Number of participants with reported adverse events
Time Frame
Baseline to 120 days
Title
Illness Questionnaire
Description
Parent reported number of sick episodes, sick days, healthcare visits and symptoms, with higher number reported being less favorable
Time Frame
Baseline to 120 days
Title
Mid Upper Arm Muscle Circumference (MUAMC) Calculation
Description
Changes in MUAMC calculations
Time Frame
Baseline to 30 days and 120 days
Title
Arm Muscle Area (AMA) Calculation
Description
Changes in AMA calculations
Time Frame
Baseline to 30 days and 120 days
Title
Arm Fat Area (AFA) Calculation
Description
Changes in AFA calculations
Time Frame
Baseline to 30 days and 120 days
Title
Arm Fat Index (AFI) Calculation
Description
Changes in AFI calculations
Time Frame
Baseline to 30 days and 120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child is between 1 year 0 days to 5 years 364 days old at enrolment
Undernourished or at risk of undernutrition, defined as:
WHZ <- 1 and HAZ <-1 for children up to 4 years 364 days, according to the WHO Growth Standards; or
BMIAZ <-1 and HAZ <-1 for children 5 years 0 days and older, according to the WHO Growth Reference Standards
Child is not currently breastfed
Child's parent(s)/LG is willing to abstain from giving additional non-study Oral Nutritional Supplement (ONS) other than the study product during the study intervention period
Child is a singleton
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:
Child 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 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 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:
Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
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
Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay
Disorders of hemoglobin structure, function or synthesis
Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product)
Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen Ling Mandy Ow, PhD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Nutritional Supplementation in Children at Risk of Undernutrition
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