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

Overview

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

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.