CompletedNot Applicable

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

United States41 participantsStarted 2021-08-27

Plain-language summary

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).

Who can participate

Age range

12 Months – 36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dietary intake from solid foods - Total proteins in grams

Timeframe: At baseline

Dietary intake from solid foods - Total grains in grams

Timeframe: At baseline

Dietary intake from solid foods - Total vegetables in cups

Timeframe: At baseline

Dietary intake from solid foods - Total proteins in grams

Timeframe: At 3 months

Dietary intake from solid foods - Total grains in grams

Timeframe: At 3 months

Dietary intake from solid foods - Total vegetables in cups

Timeframe: At 3 months

Trial details

NCT IDNCT05088590

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

View on ClinicalTrials.gov More Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition trials

Plain-language summary

Who can participate

Age range

12 Months – 36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

What they're measuring

Dietary intake from solid foods - Total proteins in grams

Timeframe: At baseline

Dietary intake from solid foods - Total grains in grams

Timeframe: At baseline

Dietary intake from solid foods - Total vegetables in cups

Timeframe: At baseline

Dietary intake from solid foods - Total proteins in grams

Timeframe: At 3 months

Dietary intake from solid foods - Total grains in grams

Timeframe: At 3 months

Dietary intake from solid foods - Total vegetables in cups

Timeframe: At 3 months