The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants

This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.

Study Overview

• Status: Completed
• Conditions: Growth of Term Infants
• Intervention / Treatment: Other: An investigational infant formula containing an alternate source of DHA; Other: Control: Marketed routine infant formula

• Study Type: Interventional
• Enrollment (Anticipated): 315
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates
    • Birmingham, Alabama, United States, 35244
      • Greenvale Pediatrics - Hoover
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Association
    • 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, PC
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Children's Research, LLC
    • Sarasota, Florida, United States, 34239
      • Physician Care Clinical Research
  • Indiana
    • Evansville, Indiana, United States, 47725
      • Deaconess Clinical Research
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Pediatrics
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
      • Woburn Pediatic Associates
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Cary Pediatric Center
    • Raleigh, North Carolina, United States, 27609
      • Capital Pediatrics & Adolescent Center
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates of Mt. Carmel, Inc
    • 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
    • Austin, Texas, United States, 78745
      • Austin Diagnostic Clinic
    • 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: No
• 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:

• History of underlying metabolic or chronic disease or immunocompromised
• Feeding difficulties or formula intolerance

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infant formula containing an alternate source of DHA	Other: An investigational infant formula containing an alternate source of DHA
Active Comparator: Marketed routine infant formula	Other: Control: Marketed routine infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight measured at each study visit	3.5 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recall of infant formula intake at each study visit		3.5 months
Body length measured at each study visit		3.5 months
Recall of stool consistency measured at each study visit		3.5 months
Medically-confirmed adverse events collected throughout the study period		3.5 months
Head circumference measured at each study visit		3.5 months
Recall of gastrointestinal tolerance measured at each study visit		3.5 months
Blood Collection	Blood Collection from a subset of participants to measure levels of fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA).	Once at 120 days of age

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Investigators: Study Director: Carol Lynn Berseth, M.D., Mead Johnson and Company

Publications and helpful links

General Publications

• Yeiser M, Harris CL, Kirchoff AL, Patterson AC, Wampler JL, Zissman EN, Berseth CL. Growth and tolerance of infants fed formula with a new algal source of docosahexaenoic acid: Double-blind, randomized, controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:89-96. doi: 10.1016/j.plefa.2016.09.001. Epub 2016 Sep 29.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 3386-1