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Growing-up Formula

Growing Up Formula vs Nutritional Supplements for Toddler Malnutrition (KEEP Growing Trial)

N/A
Recruiting
Led By Liliane Diab, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy toddlers 12-36 months of age with mild or moderate malnutrition meeting 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, BMI z-score between -1 to -2.9 for children between 2 and 3 years of age using the CDC growth standards, Middle upper-arm circumference (MUAC) z-scores between -1 to -2.9 using the WHO growth references, Percentage of median ideal body weight of 70-89% using growth standards.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months
Awards & highlights

KEEP Growing Trial Summary

This trial will compare a growing-up formula to a common nutritional supplement to see if the GUF helps picky eaters increase solid food intake and improve growth.

Who is the study for?
This trial is for toddlers aged 12-36 months with mild to moderate malnutrition, as indicated by specific growth measurements like weight-for-length or BMI z-scores. It's aimed at those who may not eat enough solid foods and need nutritional support.Check my eligibility
What is being tested?
The study compares a growing-up formula (Enfagrow) with a common children's nutritional supplement (Pediasure). The goal is to see if Enfagrow can help these toddlers eat more solid food and improve their growth compared to Pediasure.See study design
What are the potential side effects?
Potential side effects are not specified in the provided information but could include digestive issues such as constipation or diarrhea, allergic reactions, or changes in appetite.

KEEP Growing Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My toddler is mildly or moderately malnourished according to health standards.

KEEP Growing Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dietary intake from solid foods - Total grains in grams
Dietary intake from solid foods - Total proteins in grams
Dietary intake from solid foods - Total vegetables in cups
Secondary outcome measures
Measures Related to Growth and Nutrition
Measures Related to Growth and Nutrition -- Weight gain

KEEP Growing Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Growing Up Formula (GUF)Experimental Treatment1 Intervention
Group II: Standard Nutritional Supplement (NS)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

Children's Hospital ColoradoOTHER
116 Previous Clinical Trials
5,132,465 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,376 Total Patients Enrolled
9 Trials studying Malnutrition
9,383 Patients Enrolled for Malnutrition
Mead Johnson NutritionIndustry Sponsor
79 Previous Clinical Trials
16,218 Total Patients Enrolled
2 Trials studying Malnutrition
341 Patients Enrolled for Malnutrition

Media Library

Enfagrow® Neuropro Toddler Nutritional Drink (Growing-up Formula) Clinical Trial Eligibility Overview. Trial Name: NCT05088590 — N/A
Malnutrition Research Study Groups: Growing Up Formula (GUF), Standard Nutritional Supplement (NS)
Malnutrition Clinical Trial 2023: Enfagrow® Neuropro Toddler Nutritional Drink Highlights & Side Effects. Trial Name: NCT05088590 — N/A
Enfagrow® Neuropro Toddler Nutritional Drink (Growing-up Formula) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05088590 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Growing Up Formula Versus Nutritional Supplements: Effect on Catch up Growth, Micronutrient Status, and Solid Foods Intake in Toddlers With Mild or Moderate Malnutrition
2021. "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. https://clinicaltrials.gov/ct2/show/NCT05088590.
~13 spots leftby Aug 2024
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