Nutritional Supplementation in Children at Risk of Undernutrition

NCT ID: NCT05437068

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2022-11-11

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Oral Nutritional Supplement (ONS) Group

Two servings per day in addition to dietary counseling

Group Type: EXPERIMENTAL

Oral Nutritional Supplement (ONS)

Intervention Type: OTHER

ONS plus dietary counseling

Interventions

Oral Nutritional Supplement (ONS)

ONS plus dietary counseling

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yen Ling Mandy Ow, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Other Identifiers

AL55

Identifier Type: -

Identifier Source: org_study_id