Nutritional Supplementation in Children at Risk of Undernutrition

Malnutrition, Child Clinical Trial

Official title:

Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05437068
• Other study ID #: AL55
• Status: Withdrawn
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: November 11, 2022

Study information

• Verified date: February 2023
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child

Intervention

Other:
• Oral Nutritional Supplement (ONS)
ONS plus dietary counseling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental Evaluation of Child's Healthy Growth	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	Baseline to 30 days and 120 days
Other	Parental Assessment of Child's Sleep	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	Baseline to 30 days and 120 days
Other	Adverse Event	Number of participants with reported adverse events	Baseline to 120 days
Other	Illness Questionnaire	Parent reported number of sick episodes, sick days, healthcare visits and symptoms, with higher number reported being less favorable	Baseline to 120 days
Other	Mid Upper Arm Muscle Circumference (MUAMC) Calculation	Changes in MUAMC calculations	Baseline to 30 days and 120 days
Other	Arm Muscle Area (AMA) Calculation	Changes in AMA calculations	Baseline to 30 days and 120 days
Other	Arm Fat Area (AFA) Calculation	Changes in AFA calculations	Baseline to 30 days and 120 days
Other	Arm Fat Index (AFI) Calculation	Changes in AFI calculations	Baseline to 30 days and 120 days
Primary	Height-for-age-Z-score	Change in Height-for-age-Z-score	Baseline to 120 days
Secondary	Weight	Measured in Kg	Baseline to 30 days and 120 days
Secondary	Height	Measured in cm	Baseline to 30 days and 120 days
Secondary	Mid-Upper-Arm Circumference (MUAC)	Measured in cm	Baseline to 30 days and 120 days
Secondary	Weight-for-Height Measurement Calculations	Weight-for-height standard z scores and percentiles	Baseline to 30 days and 120 days
Secondary	Weight-for-Age Measurement Calculations	Weight-for-age standard z scores and percentiles	Baseline to 30 days and 120 days
Secondary	BMI-for-Age Measurement Calculations	BMI-for-age standard z scores and percentiles	Baseline to 30 days and 120 days
Secondary	Height-for-Age Measurement Calculations	Height-for-age standard z scores and percentiles	Baseline to 30 days and 120 days
Secondary	MUAC-for-Age Measurement Calculations	MUAC-for-age standard z scores and percentiles	Baseline to 30 days and 120 days
Secondary	Dietary Intake	Measured by 24-hour dietary recall	Baseline to 30 days and 120 days
Secondary	Appetite	Visual analog scale from 0 (Ate Very Little) to 10 (Ate Very Much) with high scores being favorable	Baseline to 30 days and 120 days
Secondary	Physical Activity	Visual analog scale from 0 (Not Active) to 10 (Very Active) with high scores being favorable	Baseline to 30 days and120 days