Healthy Toddlers 12-36 Months of Age With Mild or Moderate MalnutritionKEEP GrowingNCT05088590

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

A study testing Enfagrow® Neuropro Toddler Nutritional Drink and Pediasure® Grow & Gain Protein Shake for Kids in people with Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 36 months
Conditions the study is for: Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition
What is being tested?: Enfagrow® Neuropro Toddler Nutritional Drink and Pediasure® Grow & Gain Protein Shake for Kids
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 27 Aug 2021to 1 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 36 months
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital Colorado
Aurora, Colorado, 80045

Other trials in United States

About this study

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).

Conditions: Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition
Being tested: Enfagrow® Neuropro Toddler Nutritional Drink, Pediasure® Grow & Gain Protein Shake for Kids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enfagrow® Neuropro Toddler Nutritional DrinkDietary 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 KidsDietary supplement
Pediasure® Grow \& Gain Protein Shake for Kids to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)

Study groups in NCT05088590
Study group	Role	What they receive
Growing Up Formula (GUF)	Experimental	Not described Receives: Dietary Supplement: Enfagrow® Neuropro Toddler Nutritional Drink
Standard Nutritional Supplement (NS)	Active comparator	Not described Receives: Dietary Supplement: Pediasure® Grow & Gain Protein Shake for Kids

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: At baseline
Dietary intake from solid foods - Total grains 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
Measured: At baseline
Dietary intake from solid foods - Total vegetables in cups
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
Measured: 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
Measured: At 3 months
Dietary intake from solid foods - Total grains 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
Measured: At 3 months
Dietary intake from solid foods - Total vegetables in cups
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
Measured: At 3 months

Secondary outcomes (2)

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
Measured: 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[
Measured: Change from baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 20211 Dec 2024

First posted22 Oct 2021
Study start27 Aug 2021
Primary completion1 Nov 2024
Study completion1 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Toddlers 12-36 Months of Age With Mild or Moderate MalnutritionStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05088590
Sponsor's protocol ID: 20-3082
Acronym: KEEP Growing
Status last verified: Feb 2025
First submitted: 3 Sep 2021
Last updated: 17 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05088590
Acronym / sponsor ID: KEEP Growing / 20-3082
Conditions: Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: Children's Hospital Colorado, Mead Johnson Nutrition
Study start: 27 Aug 2021 (actual)
Primary completion: 1 Nov 2024 (actual)
Study completion: 1 Dec 2024 (actual)
First posted: 22 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Growing Up Formula (GUF)	Experimental	Dietary Supplement: Enfagrow® Neuropro Toddler Nutritional Drink
Standard Nutritional Supplement (NS)	Active comparator	Dietary Supplement: Pediasure® Grow & Gain Protein Shake for Kids

Who may qualify

Ages: 12 to 36 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enfagrow® Neuropro Toddler Nutritional DrinkEnfagrow® Neuropro Toddler Nutritional Drink to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)	Dietary supplement	Growing Up Formula (GUF)
Pediasure® Grow & Gain Protein Shake for KidsPediasure® Grow \& Gain Protein Shake for Kids to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)	Dietary supplement	Standard Nutritional Supplement (NS)

Primary outcome

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
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
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
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
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
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

2 secondary outcomes

Secondary Outcomes Measures Related to Growth and Nutrition
Time frame: Change from baseline to 3 months
Secondary Outcomes Measures Related to Growth and Nutrition -- Weight gain
Time frame: Change from baseline to 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Liliane Diab, MD principal investigator

Children's Hospital Colorado

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary intake from solid foods - Total proteins in grams (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05088590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.