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OpenTrials
Completed

NCT Number: 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

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).

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Key information

Conditions

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

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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
  • BMI z-score between -1 to -2.9 for children between 2 and 3 years of age using the CDC growth standards; or
  • Middle upper-arm circumference (MUAC) z-scores between -1 to -2.9 using the WHO growth references; or
  • 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.

Treatment and study plan

Enfagrow® Neuropro Toddler Nutritional Drink

Dietary Supplement

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

Pediasure® Grow & Gain Protein Shake for Kids

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)

Primary outcomes

  1. Dietary intake from solid foods - Total proteins in grams

    Time frame: At baseline

    • Amount of intake of food groups from age-appropriate solid foods;
    • Intake of calories from age-appropriate solid foods;
    • Intake of micronutrients from age-appropriate solid foods;
    • Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
    • Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement

  2. Dietary intake from solid foods - Total grains in grams

    Time frame: At baseline

    • Amount of intake of food groups from age-appropriate solid foods;
    • Intake of calories from age-appropriate solid foods;
    • Intake of micronutrients from age-appropriate solid foods;
    • Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
    • Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement

  3. Dietary intake from solid foods - Total vegetables in cups

    Time frame: At baseline

    • Amount of intake of food groups from age-appropriate solid foods;
    • Intake of calories from age-appropriate solid foods;
    • Intake of micronutrients from age-appropriate solid foods;
    • Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
    • Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement

  4. Dietary intake from solid foods - Total proteins in grams

    Time frame: At 3 months

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

  5. Dietary intake from solid foods - Total grains in grams

    Time frame: At 3 months

    • Amount of intake of food groups from age-appropriate solid foods;
    • Intake of calories from age-appropriate solid foods;
    • Intake of micronutrients from age-appropriate solid foods;
    • Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
    • Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement

  6. Dietary intake from solid foods - Total vegetables in cups

    Time frame: At 3 months

    • Amount of intake of food groups from age-appropriate solid foods;
    • Intake of calories from age-appropriate solid foods;
    • Intake of micronutrients from age-appropriate solid foods;
    • Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
    • Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement

Secondary outcomes

  1. Secondary Outcomes Measures Related to Growth and Nutrition

    Time frame: Change from baseline to 3 months

    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

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

    Time frame: Change from baseline to 3 months

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Children's Hospital Colorado
  • Mead Johnson Nutrition

Registry information

Acronym: KEEP Growing

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2021
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.