NCT05437068WithdrawnNot Applicable
Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Abbott Nutrition
- Primary Endpoint
- Height-for-age-Z-score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Oral Nutritional Supplement (ONS) Group
Experimental
Two servings per day in addition to dietary counseling
Intervention: Oral Nutritional Supplement (ONS) (Other)
Outcomes
Primary Outcomes
Height-for-age-Z-score
Time Frame: Baseline to 120 days
Change in Height-for-age-Z-score
Secondary Outcomes
- Height(Baseline to 30 days and 120 days)
- BMI-for-Age Measurement Calculations(Baseline to 30 days and 120 days)
- Weight(Baseline to 30 days and 120 days)
- Dietary Intake(Baseline to 30 days and 120 days)
- Appetite(Baseline to 30 days and 120 days)
- Weight-for-Height Measurement Calculations(Baseline to 30 days and 120 days)
- Physical Activity(Baseline to 30 days and120 days)
- Weight-for-Age Measurement Calculations(Baseline to 30 days and 120 days)
- Height-for-Age Measurement Calculations(Baseline to 30 days and 120 days)
- Mid-Upper-Arm Circumference (MUAC)(Baseline to 30 days and 120 days)
- MUAC-for-Age Measurement Calculations(Baseline to 30 days and 120 days)
Investigators
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