NCT02481531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
373

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

June 19, 2015

Last Update Submit

March 24, 2017

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • Body weight measured at each study visit

    Measurement collected with a calibrated infant scale

    12 months

Secondary Outcomes (6)

  • Body length measured at each study visit

    12 months

  • Head circumference measured at each study visit

    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

    Once at 12 months

  • +1 more secondary outcomes

Study Arms (2)

Previously marketed infant formula

ACTIVE COMPARATOR

Cow's milk-based infant formula

Other: Previously marketed infant formula

Previously marketed formula using a similar protein

EXPERIMENTAL

Cow's milk-based infant formula

Other: Previously marketed formula using a similar protein

Interventions

Previously marketed infant formulaOTHER
Previously marketed infant formula
Previously marketed formula using a similar proteinOTHER
Previously marketed formula using a similar protein

Eligibility Criteria

Age10 Days - 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Birmingham Pediatric Associates

Birmingham, Alabama, 35205, United States

Location

Southeastern Pediatric Associates

Dothan, Alabama, 36305, United States

Location

Pediatrics East - Alabama Clinical Therapeutics

Pinson, Alabama, 35126, United States

Location

Northwest Arkansas Pediatric Clinic

Fayetteville, Arkansas, 72703, United States

Location

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, 72401, United States

Location

Norwich Pediatric Group, P.C.

Norwich, Connecticut, 06360, United States

Location

Children's Research, LLC

Altamonte Springs, Florida, 32701, United States

Location

Deaconess Clinical Research

Evansville, Indiana, 47725, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Kentucky Pediatrics/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Owensboro Pediatrics

Owensboro, Kentucky, 42303, United States

Location

Woburn Pediatic Associates

Woburn, Massachusetts, 01801, United States

Location

Pediatric Associates of Mt. Carmel, Inc

Cincinnati, Ohio, 45245, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, 45014, United States

Location

UHMP Comprehensive Pediatrics

Westlake, Ohio, 44145, United States

Location

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

The Jackson Clinic - North Jackson

Jackson, Tennessee, 38305, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Related Publications (1)

  • Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.

    PMID: 37929831DERIVED

Study Officials

  • Steven Wu, M.D.

    Mead Johnson and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 25, 2015

Study Start

July 1, 2015

Primary Completion

December 15, 2016

Study Completion

December 15, 2016

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

US(22)