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

February 13, 2025 updated by: University of Colorado, Denver
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Growing Up Formula (GUF)
Dietary supplement: Enfagrow® Neuropro Toddler Nutritional Drink
Enfagrow® Neuropro Toddler Nutritional Drink to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)
Active Comparator: Standard Nutritional Supplement (NS)
Dietary supplement: Pediasure® Grow & Gain Protein Shake for Kids
Pediasure® Grow & Gain Protein Shake for Kids to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dietary intake from solid foods - Total proteins in grams
Time Frame: At baseline
  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
At baseline
Dietary intake from solid foods - Total grains in grams
Time Frame: At baseline
  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
At baseline
Dietary intake from solid foods - Total vegetables in cups
Time Frame: At baseline
  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
At baseline
Dietary intake from solid foods - Total proteins in grams
Time Frame: At 3 months
  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
At 3 months
Dietary intake from solid foods - Total grains in grams
Time Frame: At 3 months
  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
At 3 months
Dietary intake from solid foods - Total vegetables in cups
Time Frame: At 3 months
  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
At 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 3 months
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[
Change from baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital Colorado
Mead Johnson Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liliane Diab, MD, Children's Hospital Colorado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-3082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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