Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns

Not Applicable

Completed

• Conditions: Learning; Growth; Toddlers
• Interventions: Other: Fortified Cow's Milk-Based Oral Nutritional Supplement

• Registration Number: NCT04766346
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This open-label clinical trial will gain evidence of the effect of an oral Nutritional Supplement (NS) to help improve catch-up growth and support learning skills in children with growth concerns.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Study Start: 2021-02-26
• Primary Completion: 2022-08-16
• Study Completion: 2022-10-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutritional Supplement	Fortified Cow's Milk-Based Oral Nutritional Supplement	The NS is a fortified cow's milk-based product provided in powdered form.

Primary Outcome Measures

Name	Time	Method
The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.	Day 1 to Day 113	The primary endpoint is the change in weight-for-length/height z-score

Secondary Outcome Measures

Name	Time	Method
Sub-scapular skinfold thickness	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113	Measurement of sub-scapular skinfold thickness in mm
Suprailiac skinfold thickness	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113	Measurement of suprailiac skinfold thickness in mm
Weight	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113	Measurement of Weight in grams
Length/height	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113	Measurement of length/height in cms
BMI	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113	BMI will be calculated and expressed in Kg/m2
Triceps skin fold thickness	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113	Measurement of triceps skinfold thickness
Z scores and percentiles	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113	1) Sex-age-specific weight, length/height, BMI and triceps and subscapular skinfold thickness percentiles and Z-scores calculated according to WHO standards. 2) Changes from baseline in sex-age-specific percentiles and Z-scores
Nutrient intake	Day 22, Day 43, Day 113	Nutrient intake from 3-day Food Intake Diaries that will be completed at home for two weekdays and 1 weekend day
Temperament and behavior	Day 1, Day 113	Temperament and behaviour scores from the Early Childhood Behavior Questionnaire- Short Form (ECBQ-SF) completed. The ECBQ-SF has 107 questions and assesses dimensions of temperament such as activity Level/Energy, attentional Focusing, attentional Shifting, cuddliness, discomfort, fear, frustration, high-intensity Pleasure, impulsivity, inhibitory Control, low-intensity Pleasure, motor Activation, perceptual Sensitivity, positive Anticipation, sadness, shyness, sociability and soothability.The scale items ask parents to report on the frequency of specific behaviours in frequently occurring contexts on a 7 point likert scale ranging from never to always.
Learning skills	Day 1, Day 113	Learning Scores derived from the Ages and Stages Questionnaire, Third Edition (ASQ-3) (with a focus on communication and problem-solving skills)
Child and parent well-being reported from the parents' perspective	Day 1, Day 113	Child health-related quality of life scores assessed using the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). The ITQOL-SF47 has 47 questions and assesses domains such as the overall health, physical abilities, growth and development, bodily pain/discomfort, temperament and moods, general health perceptions, parent impact - emotional, parent impact - time and family cohesion with a score of 0 (worst) to 100 (best) for each of these domains.
Product acceptance	Day 22, Day 64, Day 113	Product acceptance scores from the Toddler Milk Satisfaction Questionnaire
Product acceptance including child-liking and post-ingestive effects	Day 22, Day 64, Day 113	Primary facial expression valence and child heart rate variability derived from the ANURA for Research (smartphone app) while child is consuming one serving of the NS

Trial Locations

Locations (1)

Las Piñas Doctors Hospital; 🇵🇭 Las Piñas, Philippines