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

University of Colorado, Denver41 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 36 Months

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Dietary intake from solid foods - Total proteins in grams

1. Amount of intake of food groups from age-appropriate solid foods; 2. Intake of calories from age-appropriate solid foods; 3. Intake of micronutrients from age-appropriate solid foods; 4. Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement; 5. Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement

Time frame: At baseline

Dietary intake from solid foods - Total grains in grams

Time frame: At baseline

Dietary intake from solid foods - Total vegetables in cups

Time frame: At baseline

Dietary intake from solid foods - Total proteins in grams

1. Amount of intake of food groups (total proteins in grams, total grains in grams) from age-appropriate solid foods; 2. Intake of calories from age-appropriate solid foods; 3. Intake of micronutrients from age-appropriate solid foods; 4. Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement; 5. Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement

Time frame: At 3 months

Dietary intake from solid foods - Total grains in grams

Time frame: At 3 months

Dietary intake from solid foods - Total vegetables in cups

Time frame: At 3 months

Secondary Outcomes

Secondary Outcomes Measures Related to Growth and Nutrition

Change in micronutrient status between baseline and month 3 as assessed through circulating micronutrient status, measured by laboratory assessment: CBC, Ferritin, sed rate, zinc, DHA, and vitamin D

Time frame: Change from baseline to 3 months

Secondary Outcomes Measures Related to Growth and Nutrition -- Weight gain

Nutrition status assessment - Change in weight Weight gain: catch up growth is defined by weight gain of \>6 g per day\[

Time frame: Change from baseline to 3 months

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

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes