Clinical trial NCT03487094: Growth and Tolerance of Infants Fed Formula for 16 Weeks
Official title: Growth Monitoring Study of Infants Fed Formula for 16 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Lead sponsor: Nature's One
Sponsor class: INDUSTRY
First posted: 2018-04-03
Enrollment: 216
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-Investigator, Prospective, Randomized Clinical Trial
Primary purpose: OTHER

Brief summary: Growth and Tolerance Trial of Iron-fortified infant formulas

Detailed description: 16 WEEK GROWTH AND TOLERANCE

Eligibility criteria: Inclusion Criteria:

* Healthy term infants, 37-42 weeks gestational age

Exclusion Criteria:

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

Primary outcomes:
measure: Growth
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Visions Clinical Research-Tucson
state: Arizona
city: Newport
country: United States
facility: Harris Pediatric Clinic
state: Arkansas
city: Searcy
country: United States
facility: Searcy Medical Center
state: Arkansas
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: Delray Beach
country: United States
facility: Pediatrics by the Sea
state: Florida
city: Lake Mary
country: United States
facility: Altamonte Pediatric Associates
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: College Park
country: United States
facility: Paramount Research Solutions
state: Georgia
city: Evansville
country: United States
facility: Qualmedica Research
state: Indiana
city: Owensboro
country: United States
facility: Qualmedica Research
state: Kentucky
city: Shreveport
country: United States
facility: Portico Pediatrics
state: Louisiana
city: Millersville
country: United States
facility: Gvozden Pediatrics
state: Maryland
city: Valley Stream
country: United States
facility: Valley Stream Pediatrics_Lashley
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Pediatric Partners
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
city: Columbus
country: United States
facility: Aventiv Research, Inc
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Westlake
country: United States
facility: Cynthia Strieter-Boland, MD
state: Ohio
city: Bensalem
country: United States
facility: Red Lion Pediatrics
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: San Antonio
country: United States
facility: Southwestern Children's Research Associates, PA
state: Texas
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
Study officials:
affiliation: Consultant
name: Robert D Murray, MD
role: STUDY_DIRECTOR
References: