What side effects are associated with this type of intervention?

Nutritional supplements and growing-up formulas (GUF) like Enfagrow, designed to support growth and increase solid food intake in toddlers, generally have a good safety profile. Common side effects may include gastrointestinal issues such as bloating, gas, diarrhea, or constipation. These side effects are typically mild and transient. It is important to monitor for any allergic reactions, although these are rare. Overall, these treatments are well-tolerated and effective in promoting growth and nutritional status in malnourished toddlers.

What prior FDA approvals exist?

The FDA has approved various nutritional supplements and formulas aimed at treating malnutrition, particularly in children. Products like Pediasure, which is a standard nutritional supplement, have been widely used to support weight gain and growth in toddlers with mild to moderate malnutrition. These supplements are designed to provide essential nutrients and calories to help children achieve a healthy weight and improve their overall nutritional status. Similar to Enfagrow, these products are formulated to enhance solid food intake and support growth in young children.

What other types of research exist?

A promising alternative to Enfagrow for treating malnutrition in toddlers is a ready-to-use therapeutic food (RUTF) with a higher milk content, specifically one containing 25% milk. Studies have shown that RUTFs with 25% milk are more effective in treating severe acute malnutrition (SAM) in children compared to those with lower milk content. Additionally, standard nutritional supplements like Pediasure, which are commonly used to support weight gain and growth in toddlers, remain a viable option.

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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

No Placebo-Only Group

Summary

This trial tests if a special formula called Enfagrow helps picky-eating toddlers eat more solid food and grow better. It focuses on young children who struggle with eating and gaining weight.

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Measures Related to Growth and Nutrition

Measures Related to Growth and Nutrition -- Weight gain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for malnutrition, such as growing-up formulas (GUF) like Enfagrow, work by providing a balanced mix of macronutrients (proteins, fats, carbohydrates) and essential micronutrients (vitamins, minerals) that are crucial for growth and development. These formulas are designed to address nutritional deficiencies, support weight gain, and promote the intake of solid foods. This is particularly important for malnutrition patients, especially toddlers, as it helps ensure they receive the necessary nutrients for optimal physical growth, cognitive development, and immune function, thereby improving their overall health and well-being.