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

Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns: a Prospective, Single-arm, Open-label, Interventional Study

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.

Study Overview

• Status: Completed
• Conditions: Growth; Learning; Toddlers
• Intervention / Treatment: Other: Fortified Cow's Milk-Based Oral Nutritional Supplement

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Las Piñas, Philippines, 1742
    • Las Pinas Doctors Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

1. Evidence of a personally signed and dated informed consent document indicating that the child's parent(s) / legally acceptable representative (LAR) has been informed of all pertinent aspects of the study.
2. Child was full-term at birth (i.e., ≥ 37 completed weeks of gestation with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg).
3. Child is age 12 - 36 months and generally healthy (acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot & mouth disease at time of enrolment is permitted).
4. Children whose parents show some concern about their child's growth, such as child is too thin for his or her length/height, child has experienced recent rapid weight loss or failure to gain weight or length/height, or child's growth curve shows a downward trajectory of growth velocity
5. Child has a weight-for-length/height ≤ 25th percentile as per WHO growth charts.
6. Parents agree to feed their child a nutritional supplement in addition to normal diet.
7. Child's parent(s) / guardian can be contacted directly by telephone or email throughout the study.
8. Child's parent is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.

EXCLUSION CRITERIA

1. Child is currently breastfed or is consuming breast milk
2. Child has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy, fish oil intolerance / allergy, or other food allergies that impact diet.
3. Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded
4. Child has chronic illness or other disease including any condition that impacts feeding or growth
5. Child having any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g., short bowel syndrome) potentially affecting feeding or growth
6. Child has been diagnosed with Infantile anorexia nervosa
7. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study.
8. Child or child's parent(s) not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
9. Child of any investigational site staff member or Nestlé employee directly involved in the conduct of the trial.
10. Child is currently participating in or has participated in another clinical trial within 4 weeks prior to enrolment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Supplement; The NS is a fortified cow's milk-based product provided in powdered form.	Other: Fortified Cow's Milk-Based Oral Nutritional Supplement; The NS is a fortified cow's milk-based product provided in powdered form that provides the appropriate amount of energy and protein to promote growth in children.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Measurement of Weight in grams	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Length/height	Measurement of length/height in cms	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Triceps skin fold thickness	Measurement of triceps skinfold thickness	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Sub-scapular skinfold thickness	Measurement of sub-scapular skinfold thickness in mm	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Suprailiac skinfold thickness	Measurement of suprailiac skinfold thickness in mm	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
BMI	BMI will be calculated and expressed in Kg/m2	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Z scores and percentiles	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	Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Nutrient intake	Nutrient intake from 3-day Food Intake Diaries that will be completed at home for two weekdays and 1 weekend day	Day 22, Day 43, Day 113
Learning skills	Learning Scores derived from the Ages and Stages Questionnaire, Third Edition (ASQ-3) (with a focus on communication and problem-solving skills)	Day 1, Day 113
Temperament and behavior	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.	Day 1, Day 113
Child and parent well-being reported from the parents' perspective	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.	Day 1, Day 113
Product acceptance	Product acceptance scores from the Toddler Milk Satisfaction Questionnaire	Day 22, Day 64, Day 113
Product acceptance including child-liking and post-ingestive effects	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	Day 22, Day 64, Day 113

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment	Data from standard AE reporting (including common illnesses) for safety assessment from date of ICF signing through 30 days after the last day of NS intake.	Day -7 to Day 113 + 30
Sick days	Total number of sick days	Day -7 to Day 113 + 30
Concomittant medications and treatment	All concomitant medications / treatments used to treat illnesses and other conditions will be recorded (both dose and duration) through 30 days after the last day of NS intake.	Day -7 to Day 113 + 30

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20.09.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No