Growth and Tolerance of Infants Fed Formula for 16 Weeks

July 9, 2020 updated by: Nature's One

Growth Monitoring Study of Infants Fed Formula for 16 Weeks

Growth and Tolerance Trial of Iron-fortified infant formulas

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

16 WEEK GROWTH AND TOLERANCE

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research-Tucson
    • Arkansas
      • Newport, Arkansas, United States, 72112
        • Harris Pediatric Clinic
      • Searcy, Arkansas, United States, 72143
        • Searcy Medical Center
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Norwich Pediatric Group, PC
    • Florida
      • Delray Beach, Florida, United States, 33483
        • Pediatrics by the Sea
      • Lake Mary, Florida, United States, 32746
        • Altamonte Pediatric Associates
      • Miami, Florida, United States, 33175
        • New Horizon Research Center
    • Georgia
      • College Park, Georgia, United States, 30349
        • Paramount Research Solutions
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research
    • Kentucky
      • Owensboro, Kentucky, United States, 43201
        • Qualmedica Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Portico Pediatrics
    • Maryland
      • Millersville, Maryland, United States, 21108
        • Gvozden Pediatrics
    • New York
      • Valley Stream, New York, United States, 11580
        • Valley Stream Pediatrics_Lashley
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Carolina Institute for Clinical Research
      • Raleigh, North Carolina, United States, 27609
        • Pediatric Partners
      • Statesville, North Carolina, United States, 28625
        • Piedmont HealthCare
    • Ohio
      • Columbus, Ohio, United States, 43123
        • Aventiv Research, Inc
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Association
      • Westlake, Ohio, United States, 44145
        • Cynthia Strieter-Boland, MD
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Red Lion Pediatrics
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Associates
      • North Charleston, South Carolina, United States, 29406
        • Coastal Pediatric Research
    • Texas
      • San Antonio, Texas, United States, 78229
        • Southwestern Children's Research Associates, PA
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Pediatric Research of Charlottesville, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy term infants, 37-42 weeks gestational age

Exclusion Criteria:

  • Any condition that would negatively impact assessment of growth and tolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Growth, Tolerance of Infants-Exp
Infant Formula
Other: Infant formula
Multi-centered, prospective, randomized clinical trial
Active Comparator: Growth,Tolerance of Infants-Com
Infant Formula
Other: Infant formula
Multi-centered, prospective, randomized clinical trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: 16 weeks
Weight Gain
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nature's One

Investigators

  • Study Director: Robert D Murray, MD, Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Actual)

July 9, 2020

Study Completion (Actual)

July 9, 2020

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

April 3, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • N1.2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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