Clinical trial NCT02481531: Growth and Tolerance of Cow's Milk-Based Infant Formulas
Official title: Growth and Tolerance of Cow's Milk-Based Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2015-06-25
Enrollment: 373
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.


Eligibility criteria: Inclusion Criteria:

* Singleton, 10-14 days of age at randomization
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Anemia at time of birth
* Current use of iron or iron-containing supplements
* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or formula intolerance

Primary outcomes:
measure: Body weight measured at each study visit
timeFrame: 12 months
Secondary outcomes:
measure: Body length measured at each study visit
timeFrame: 12 months
measure: Head circumference measured at each study visit
timeFrame: 12 months
measure: Parental recall of study formula intake at each study visit
timeFrame: 12 months
measure: Parental recall of stool consistency measured at each study visit
timeFrame: 12 months
measure: Blood Collection
timeFrame: Once at 12 months
measure: Medically-confirmed adverse events collected throughout the study period
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Pinson
country: United States
facility: Pediatrics East - Alabama Clinical Therapeutics
state: Alabama
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Norwich
country: United States
facility: Norwich Pediatric Group, P.C.
state: Connecticut
city: Altamonte Springs
country: United States
facility: Children's Research, LLC
state: Florida
city: Evansville
country: United States
facility: Deaconess Clinical Research
state: Indiana
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatrics/Adult Research
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Pediatrics
state: Kentucky
city: Woburn
country: United States
facility: Woburn Pediatic Associates
state: Massachusetts
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel, Inc
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Fairfield
country: United States
facility: Pediatric Associates of Fairfield, Inc.
state: Ohio
city: Westlake
country: United States
facility: UHMP Comprehensive Pediatrics
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic - North Jackson
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
Study officials:
affiliation: Mead Johnson and Company
name: Steven Wu, M.D.
role: STUDY_DIRECTOR
References: