Clinical trial 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
Official title: Growing Up Formula Versus Nutritional Supplements: Effect on Catch up Growth, Micronutrient Status, and Solid Foods Intake in Toddlers With Mild or Moderate Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
name: Mead Johnson Nutrition
First posted: 2021-10-22
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Dietary intake from solid foods - Total proteins in grams
timeFrame: At baseline
measure: Dietary intake from solid foods - Total grains in grams
timeFrame: At baseline
measure: Dietary intake from solid foods - Total vegetables in cups
timeFrame: At baseline
measure: Dietary intake from solid foods - Total proteins in grams
timeFrame: At 3 months
measure: Dietary intake from solid foods - Total grains in grams
timeFrame: At 3 months
measure: Dietary intake from solid foods - Total vegetables in cups
timeFrame: At 3 months
Secondary outcomes:
measure: Secondary Outcomes Measures Related to Growth and Nutrition
timeFrame: Change from baseline to 3 months
measure: Secondary Outcomes Measures Related to Growth and Nutrition -- Weight gain
timeFrame: Change from baseline to 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Liliane Diab, MD
role: PRINCIPAL_INVESTIGATOR
References: