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

Last updated: February 13, 2025
Sponsor: University of Colorado, Denver
Overall Status: Completed

Phase

N/A

Condition

Weight Loss

Diet And Nutrition

Treatment

Pediasure® Grow & Gain Protein Shake for Kids

Enfagrow® Neuropro Toddler Nutritional Drink

Clinical Study ID

NCT05088590
20-3082
  • Ages 12-36
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Healthy toddlers 12-36 months of age with mild or moderate malnutrition will be defined by at least one of the following indicators:

  1. Weight-for-length z-score between -1.0 and -2.9 for children less than 2 years ofage using the WHO growth standards; or

  2. BMI z-score between -1 to -2.9 for children between 2 and 3 years of age using theCDC growth standards; or

  3. Middle upper-arm circumference (MUAC) z-scores between -1 to -2.9 using the WHOgrowth references; or

  4. Percentage of median ideal body weight of 70-89% (using the 50th percentile of theaforementioned growth standards).

Exclusion

Exclusion Criteria:

  • Toddlers currently on or with history of tube feeding or with chronic healthconditions that influence eating (e.g., food allergies, genetic disorders ordevelopmental disabilities, oral motor difficulties that require sensory or feedingtherapy).

  • Toddlers who were born at less than 34 weeks gestation, as they may have lingeringfeeding challenges.

  • Toddlers with gastroesophageal reflux disease (GERD) requiring medications orhydrolyzed formula or any type of esophageal disorders will be excluded.

  • Toddlers with a history of infant reflux will not be excluded. The PI will make thisdistinction after a detailed history and record review.

  • Families who do not speak English or Spanish in the home.

  • Toddlers with suspected malabsorption or conditions that increased metabolic demandssuch as congenital heart defects.

  • Toddlers who have a diagnosed allergy to cow's milk.

The PI will use their clinical discretion to ascertain patient eligibility.

Study Design

Total Participants: 41
Treatment Group(s): 2
Primary Treatment: Pediasure® Grow & Gain Protein Shake for Kids
Phase:
Study Start date:
August 27, 2021
Estimated Completion Date:
December 01, 2024

Connect with a study center

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

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