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NCT03487094 Clinical Trial

Growth and Tolerance of Infants Fed Formula for 16 Weeks

Child Development Clinical Trial

Official title:
Growth Monitoring Study of Infants Fed Formula for 16 Weeks

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03487094
Other study ID # N1.2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 18, 2018
Est. completion date July 9, 2020

Study information
Verified date July 2020
Source Nature's One
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Growth and Tolerance Trial of Iron-fortified infant formulas

Description:

16 WEEK GROWTH AND TOLERANCE

Recruitment information / eligibility
Status Completed
Enrollment 216
Est. completion date July 9, 2020
Est. primary completion date July 9, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 14 Days
Eligibility Inclusion Criteria:

- Healthy term infants, 37-42 weeks gestational age

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Infant formula
Multi-centered, prospective, randomized clinical trial

Locations
Country Name City State
United States Red Lion Pediatrics Bensalem Pennsylvania
United States Coastal Pediatric Associates Charleston South Carolina
United States Pediatric Research of Charlottesville, LLC Charlottesville Virginia
United States Paramount Research Solutions College Park Georgia
United States Aventiv Research, Inc Columbus Ohio
United States Ohio Pediatric Research Association Dayton Ohio
United States Pediatrics by the Sea Delray Beach Florida
United States Qualmedica Research Evansville Indiana
United States Carolina Institute for Clinical Research Fayetteville North Carolina
United States Altamonte Pediatric Associates Lake Mary Florida
United States New Horizon Research Center Miami Florida
United States Gvozden Pediatrics Millersville Maryland
United States Harris Pediatric Clinic Newport Arkansas
United States Coastal Pediatric Research North Charleston South Carolina
United States Norwich Pediatric Group, PC Norwich Connecticut
United States Qualmedica Research Owensboro Kentucky
United States Pediatric Partners Raleigh North Carolina
United States Southwestern Children's Research Associates, PA San Antonio Texas
United States Searcy Medical Center Searcy Arkansas
United States Portico Pediatrics Shreveport Louisiana
United States Piedmont Healthcare Statesville North Carolina
United States Visions Clinical Research-Tucson Tucson Arizona
United States Valley Stream Pediatrics_Lashley Valley Stream New York
United States Cynthia Strieter-Boland, MD Westlake Ohio

Sponsors (1)
Lead Sponsor Collaborator
Nature's One

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Growth Weight Gain 16 weeks
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