NCT05088590

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2021-08-27
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2021-10-22
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States