Growth and Tolerance of Cow's Milk-Based Infant Formulas

Not Applicable

Completed

• Conditions: Growth
• Interventions: Other: Previously marketed infant formula; Other: Previously marketed formula using a similar protein

• Registration Number: NCT02481531
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-25
• Study Start: 2015-07
• Primary Completion: 2016-12-15
• Study Completion: 2016-12-15
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

• Singleton, 10-14 days of age at randomization
• Term infant with birth weight of a minimum of 2500 grams
• Solely formula fed
• Signed Informed Consent and Protected Health Information

Exclusion Criteria

• Anemia at time of birth
• Current use of iron or iron-containing supplements
• History of underlying metabolic or chronic disease or immunocompromised
• Feeding difficulties or formula intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Previously marketed infant formula	Previously marketed infant formula	Cow's milk-based infant formula
Previously marketed formula using a similar protein	Previously marketed formula using a similar protein	Cow's milk-based infant formula

Primary Outcome Measures

Name	Time	Method
Body weight measured at each study visit	12 months	Measurement collected with a calibrated infant scale

Secondary Outcome Measures

Name	Time	Method
Body length measured at each study visit	12 months	Measurement collected with a standardized length board
Head circumference measured at each study visit	12 months	Measurement collected with a standardized measuring tape
Parental recall of study formula intake at each study visit	12 months
Parental recall of stool consistency measured at each study visit	12 months
Blood Collection	Once at 12 months	Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein
Medically-confirmed adverse events collected throughout the study period	12 months

Trial Locations

Locations (20)

The Children's Clinic of Jonesboro, P.A.; 🇺🇸 Jonesboro, Arkansas, United States

The Jackson Clinic - North Jackson; 🇺🇸 Jackson, Tennessee, United States

Holston Medical Group; 🇺🇸 Kingsport, Tennessee, United States

Owensboro Pediatrics; 🇺🇸 Owensboro, Kentucky, United States

DCOL Center for Clinical Research; 🇺🇸 Longview, Texas, United States

Children's Research, LLC; 🇺🇸 Altamonte Springs, Florida, United States

Coastal Pediatric Research; 🇺🇸 Charleston, South Carolina, United States

Birmingham Pediatric Associates; 🇺🇸 Birmingham, Alabama, United States

Northwest Arkansas Pediatric Clinic; 🇺🇸 Fayetteville, Arkansas, United States

Southeastern Pediatric Associates; 🇺🇸 Dothan, Alabama, United States

Pediatrics East - Alabama Clinical Therapeutics; 🇺🇸 Pinson, Alabama, United States

Kentucky Pediatrics/Adult Research; 🇺🇸 Bardstown, Kentucky, United States

Norwich Pediatric Group, P.C.; 🇺🇸 Norwich, Connecticut, United States

Deaconess Clinical Research; 🇺🇸 Evansville, Indiana, United States

Heartland Research Associates, LLC; 🇺🇸 Wichita, Kansas, United States

Pediatric Associates of Fairfield, Inc.; 🇺🇸 Fairfield, Ohio, United States

Pediatric Associates of Mt. Carmel, Inc; 🇺🇸 Cincinnati, Ohio, United States

UHMP Comprehensive Pediatrics; 🇺🇸 Westlake, Ohio, United States

Woburn Pediatic Associates; 🇺🇸 Woburn, Massachusetts, United States

Ohio Pediatric Research Association; 🇺🇸 Dayton, Ohio, United States