Growth and Tolerance of Infants Fed Formula for 16 Weeks

NCT ID: NCT03487094

Last Updated: 2020-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2020-07-09

Brief Summary

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Growth and Tolerance Trial of Iron-fortified infant formulas

Detailed Description

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16 WEEK GROWTH AND TOLERANCE

Conditions

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Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-Investigator, Prospective, Randomized Clinical Trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Eligible infants are randomized to commercial control or experimental product.

Study Groups

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Growth, Tolerance of Infants-Exp

Infant Formula

Group Type ACTIVE_COMPARATOR

Infant formula

Intervention Type OTHER

Multi-centered, prospective, randomized clinical trial

Growth,Tolerance of Infants-Com

Infant Formula

Group Type ACTIVE_COMPARATOR

Infant formula

Intervention Type OTHER

Multi-centered, prospective, randomized clinical trial

Interventions

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Infant formula

Multi-centered, prospective, randomized clinical trial

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy term infants, 37-42 weeks gestational age

Exclusion Criteria

* Any condition that would negatively impact assessment of growth and tolerance
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nature's One

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert D Murray, MD

Role: STUDY_DIRECTOR

Consultant

Locations

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Visions Clinical Research-Tucson

Tucson, Arizona, United States

Site Status

Harris Pediatric Clinic

Newport, Arkansas, United States

Site Status

Searcy Medical Center

Searcy, Arkansas, United States

Site Status

Norwich Pediatric Group, PC

Norwich, Connecticut, United States

Site Status

Pediatrics by the Sea

Delray Beach, Florida, United States

Site Status

Altamonte Pediatric Associates

Lake Mary, Florida, United States

Site Status

New Horizon Research Center

Miami, Florida, United States

Site Status

Paramount Research Solutions

College Park, Georgia, United States

Site Status

Qualmedica Research

Evansville, Indiana, United States

Site Status

Qualmedica Research

Owensboro, Kentucky, United States

Site Status

Portico Pediatrics

Shreveport, Louisiana, United States

Site Status

Gvozden Pediatrics

Millersville, Maryland, United States

Site Status

Valley Stream Pediatrics_Lashley

Valley Stream, New York, United States

Site Status

Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States

Site Status

Pediatric Partners

Raleigh, North Carolina, United States

Site Status

Piedmont Healthcare

Statesville, North Carolina, United States

Site Status

Aventiv Research, Inc

Columbus, Ohio, United States

Site Status

Ohio Pediatric Research Association

Dayton, Ohio, United States

Site Status

Cynthia Strieter-Boland, MD

Westlake, Ohio, United States

Site Status

Red Lion Pediatrics

Bensalem, Pennsylvania, United States

Site Status

Coastal Pediatric Associates

Charleston, South Carolina, United States

Site Status

Coastal Pediatric Research

North Charleston, South Carolina, United States

Site Status

Southwestern Children's Research Associates, PA

San Antonio, Texas, United States

Site Status

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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N1.2018

Identifier Type: -

Identifier Source: org_study_id

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