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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

CompletedNA

Sponsor: University of Colorado, Denver

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

Interventions: Enfagrow® Neuropro Toddler Nutritional Drink, Pediasure® Grow & Gain Protein Shake for Kids

Countries: United States

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 overview

Sex: ALL

Age: 12 Months to 36 Months

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Aurora, Colorado, United States