Growing Up Formula Versus Nutritional Supplements: Effect... | NCT05088590

NCT05088590

Status Module

Name	Class
Children's Hospital Colorado	OTHER
Mead Johnson Nutrition	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Growing Up Formula (GUF)	Experimental		Dietary Supplement: Enfagrow® Neuropro Toddler Nutritional Drink
Standard Nutritional Supplement (NS)	Active Comparator		Dietary Supplement: Pediasure® Grow & Gain Protein Shake for Kids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enfagrow® Neuropro Toddler Nutritional Drink	Dietary Supplement	Enfagrow® Neuropro Toddler Nutritional Drink to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	At baseline
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	At baseline
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	At baseline
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

Secondary Outcomes

Measure	Description	Time Frame
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	Change from baseline to 3 months
Secondary Outcomes Measures Related to Growth and Nutrition -- Weight gain

Eligibility Module