NCT02860026

Brief Summary

This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

17 active sites

Status
withdrawn

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

August 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

August 3, 2016

Last Update Submit

May 26, 2017

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • Rate of body weight gain from 14 to 120 days of age

    3.5 months

Secondary Outcomes (6)

  • Recall of infant formula at each study visit

    Up to 3.5 months

  • Body length measured at each study visit

    Up to 3.5 months

  • Recall of stool characteristics questionnaire measured at each study visit

    Up to 3.5 months

  • Head circumference measured at each study visit

    Up to 3.5 months

  • Recall of gastrointestinal tolerance questionnaire at each study visit

    Up to 3.5 months

  • +1 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Marketed cow's milk-based infant formula

Other: Marketed cow's milk-based infant formula

Investigational

EXPERIMENTAL

Cow's milk-based infant formula with added nutrients

Other: Cow's milk-based infant formula with added nutrients

Interventions

Marketed cow's milk-based infant formulaOTHER
Control
Cow's milk-based infant formula with added nutrientsOTHER
Investigational

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 minimum of 2500 grams
  • Solely formula fed
  • Signed informed consent and protected health information

You may not qualify if:

  • History of underlying metabolic or chronic disease, anemia, or immune compromise
  • Feeding difficulties or formula intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Birmingham Pediatric Associates

Birmingham, Alabama, 35205, United States

Location

Southeastern Pediatric Associates

Dothan, Alabama, 36305, 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

Altamonte Pediatric Associates

Lake Mary, Florida, 32746, United States

Location

Deaconess Clinical Research

Evansville, Indiana, 47725, United States

Location

Kentucky Pediatrics/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Owensboro Pediatrics

Owensboro, Kentucky, 42303, 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

Study Officials

  • Steven Wu

    Mead Johnson Nutrition

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 9, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(17)