MedTrace Logo

Growing Up Formula Versus Nutritional Supplements: Effect on Catch up Growth, Micronutrient Status, and Solid Foods Intake in Toddlers With Mild or Moderate Malnutrition

NCT05088590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-02-17

No results posted yet for this study

Summary

This is a pilot study to test how a growing-up formula (GUF) compares to a common nutritional supplement (NS), which is regularly used to help toddlers (ages 12-36 months) gain weight. This study will look at whether GUF helps to increase solid food intake for children who are thought to be "picky eaters" and see the effects on growth compared with the NS. To date, it is not clear if GUFs help to increase intake of solid foods. Participants will be placed into one of the two study arms: Enfagrow (GUF) or Pediasure (standard NS).

Conditions

  • Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition

Interventions

DIETARY_SUPPLEMENT

Enfagrow® Neuropro Toddler Nutritional Drink

Enfagrow® Neuropro Toddler Nutritional Drink to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)

DIETARY_SUPPLEMENT

Pediasure® Grow & Gain Protein Shake for Kids

Pediasure® Grow \& Gain Protein Shake for Kids to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)

Sponsors & Collaborators

  • Children's Hospital Colorado

    collaborator OTHER

  • Mead Johnson Nutrition

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Liliane Diab, MD · Children's Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2024-11-01
Completion
2024-12-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05088590 on ClinicalTrials.gov