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 range12 Months – 36 Months

SexALL

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

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 range12 Months – 36 Months

SexALL

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