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

Société des Produits Nestlé (SPN)1 site in 1 country168 target enrollmentFebruary 26, 2021

ConditionsGrowth Learning Toddlers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 168
Locations: 1
Primary Endpoint: The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 26, 2021

End Date

October 27, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.

Time Frame: Day 1 to Day 113

The primary endpoint is the change in weight-for-length/height z-score

Secondary Outcomes

Sub-scapular skinfold thickness(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
Suprailiac skinfold thickness(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
Weight(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
Length/height(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
BMI(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
Triceps skin fold thickness(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
Z scores and percentiles(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
Nutrient intake(Day 22, Day 43, Day 113)
Temperament and behavior(Day 1, Day 113)
Learning skills(Day 1, Day 113)
Child and parent well-being reported from the parents' perspective(Day 1, Day 113)
Product acceptance(Day 22, Day 64, Day 113)
Product acceptance including child-liking and post-ingestive effects(Day 22, Day 64, Day 113)