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

NCT ID: NCT05088590

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2024-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Growing Up Formula (GUF)

Group Type: EXPERIMENTAL

Enfagrow® Neuropro Toddler Nutritional Drink

Intervention Type: DIETARY_SUPPLEMENT

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

Standard Nutritional Supplement (NS)

Group Type: ACTIVE_COMPARATOR

Pediasure® Grow & Gain Protein Shake for Kids

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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)

Intervention Type: 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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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 of age 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 the CDC growth standards; or

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

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

Exclusion Criteria

• Toddlers currently on or with history of tube feeding or with chronic health conditions that influence eating (e.g., food allergies, genetic disorders or developmental disabilities, oral motor difficulties that require sensory or feeding therapy).
• Toddlers who were born at less than 34 weeks gestation, as they may have lingering feeding challenges.
• Toddlers with gastroesophageal reflux disease (GERD) requiring medications or hydrolyzed 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 this distinction 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 demands such 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Colorado

OTHER

Sponsor Role: collaborator

Mead Johnson Nutrition

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liliane Diab, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

20-3082

Identifier Type: -

Identifier Source: org_study_id