Growing Up Formula Versus Nutritional Supplements: Effect on Catch up Growth, Micronutrient Status, and Solid Foods Intake in Toddlers With Mild or Moderate Malnutrition (KEEP Growing)
Primary Purpose
Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enfagrow® Neuropro Toddler Nutritional Drink
Pediasure® Grow & Gain Protein Shake for Kids
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition
Eligibility Criteria
Inclusion Criteria:
Healthy toddlers 12-36 months of age with mild malnutrition will be defined by at least one of the following indicators:
- Weight-for-length z-score between -1.0 and -1.9 for children less than 2 years of age using the WHO growth standards; or
- BMI z-score between -1 to -1.9 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 -1.9 using the WHO growth references; or
- Percentage of median ideal body weight of 80-89% (using the 50th percentile of the aforementioned growth standards).
Exclusion Criteria:
- 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.
Sites / Locations
- Children's Hospital ColoradoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Growing Up Formula (GUF)
Standard Nutritional Supplement (NS)
Arm Description
Outcomes
Primary Outcome Measures
Dietary intake from solid foods - Total proteins in grams
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Dietary intake from solid foods - Total grains in grams
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Dietary intake from solid foods - Total vegetables in cups
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Dietary intake from solid foods - Total proteins in grams
Amount of intake of food groups (total proteins in grams, total grains in grams) from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Dietary intake from solid foods - Total grains in grams
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Dietary intake from solid foods - Total vegetables in cups
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Secondary Outcome Measures
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
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[
Full Information
NCT ID
NCT05088590
First Posted
September 3, 2021
Last Updated
March 27, 2023
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado, Mead Johnson Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT05088590
Brief 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
Acronym
KEEP Growing
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado, Mead Johnson Nutrition
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Growing Up Formula (GUF)
Arm Type
Experimental
Arm Title
Standard Nutritional Supplement (NS)
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Enfagrow® Neuropro Toddler Nutritional Drink
Intervention Description
Enfagrow® Neuropro Toddler Nutritional Drink to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)
Intervention Type
Dietary Supplement
Intervention Name(s)
Pediasure® Grow & Gain Protein Shake for Kids
Intervention Description
Pediasure® Grow & Gain Protein Shake for Kids to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)
Primary Outcome Measure Information:
Title
Dietary intake from solid foods - Total proteins in grams
Description
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Time Frame
At baseline
Title
Dietary intake from solid foods - Total grains in grams
Description
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Time Frame
At baseline
Title
Dietary intake from solid foods - Total vegetables in cups
Description
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Time Frame
At baseline
Title
Dietary intake from solid foods - Total proteins in grams
Description
Amount of intake of food groups (total proteins in grams, total grains in grams) from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Time Frame
At 3 months
Title
Dietary intake from solid foods - Total grains in grams
Description
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Time Frame
At 3 months
Title
Dietary intake from solid foods - Total vegetables in cups
Description
Amount of intake of food groups from age-appropriate solid foods;
Intake of calories from age-appropriate solid foods;
Intake of micronutrients from age-appropriate solid foods;
Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;
Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Secondary Outcomes Measures Related to Growth and Nutrition
Description
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
Time Frame
Change from baseline to 3 months
Title
Secondary Outcomes Measures Related to Growth and Nutrition -- Weight gain
Description
Nutrition status assessment - Change in weight Weight gain: catch up growth is defined by weight gain of >6 g per day[
Time Frame
Change from baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Coordinator
Phone
720-777-0106
Email
Ryan.Oakes@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liliane Diab, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Research Coordinator
Phone
720-777-0106
Email
Ryan.Oakes@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Liliane Diab, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Growing Up Formula Versus Nutritional Supplements: Effect on Catch up Growth, Micronutrient Status, and Solid Foods Intake in Toddlers With Mild or Moderate Malnutrition
We'll reach out to this number within 24 hrs