Nutritional Supplementation in Children at Risk of Undernutrition

NCT05437068 | Withdrawn

• 1 other identifier: AL55
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malnutrition, Child

Outcome Measures

Primary Outcomes (1)

• Height-for-age-Z-score

  Change in Height-for-age-Z-score

  Baseline to 120 days

Secondary Outcomes (11)

• Weight

  Baseline to 30 days and 120 days

• Height

  Baseline to 30 days and 120 days

• Mid-Upper-Arm Circumference (MUAC)

  Baseline to 30 days and 120 days

• Weight-for-Height Measurement Calculations

  Baseline to 30 days and 120 days

• Weight-for-Age Measurement Calculations

  Baseline to 30 days and 120 days

Other Outcomes (8)

• Parental Evaluation of Child's Healthy Growth

  Baseline to 30 days and 120 days

• Parental Assessment of Child's Sleep

  Baseline to 30 days and 120 days

• Adverse Event

  Baseline to 120 days

Study Arms (1)

Oral Nutritional Supplement (ONS) Group

EXPERIMENTAL

Two servings per day in addition to dietary counseling

Other: Oral Nutritional Supplement (ONS)

Interventions

Oral Nutritional Supplement (ONS) OTHER

ONS plus dietary counseling

Oral Nutritional Supplement (ONS) Group

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Nutrition: lead

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yen Ling Mandy Ow, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 29, 2022
• Study Start: November 11, 2022
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share