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

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.

Study Overview

• Status: Completed
• Conditions: Growth
• Intervention / Treatment: Other: Previously marketed infant formula; Other: Previously marketed formula using a similar protein

• Study Type: Interventional
• Enrollment (Actual): 373
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates
    • Pinson, Alabama, United States, 35126
      • Pediatrics East - Alabama Clinical Therapeutics
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Northwest Arkansas Pediatric Clinic
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro, P.A.
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group, P.C.
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Children's Research, LLC
  • Indiana
    • Evansville, Indiana, United States, 47725
      • Deaconess Clinical Research
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Heartland Research Associates, LLC
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates, LLC
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatrics/Adult Research
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Pediatrics
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
      • Woburn Pediatic Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates of Mt. Carmel, Inc
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
    • Fairfield, Ohio, United States, 45014
      • Pediatric Associates of Fairfield, Inc.
    • Westlake, Ohio, United States, 44145
      • UHMP Comprehensive Pediatrics
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic - North Jackson
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Previously marketed infant formula; Cow's milk-based infant formula	Other: Previously marketed infant formula
Experimental: Previously marketed formula using a similar protein; Cow's milk-based infant formula	Other: Previously marketed formula using a similar protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight measured at each study visit	Measurement collected with a calibrated infant scale	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body length measured at each study visit	Measurement collected with a standardized length board	12 months
Head circumference measured at each study visit	Measurement collected with a standardized measuring tape	12 months
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	Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein	Once at 12 months
Medically-confirmed adverse events collected throughout the study period		12 months

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Investigators: Study Director: Steven Wu, M.D., Mead Johnson and Company

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 15, 2016
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 3387-1