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NCT02481531 Clinical Trial

Growth and Tolerance of Cow's Milk-Based Infant Formulas

Growth Clinical Trial

Official title:
Growth and Tolerance of Cow's Milk-Based Infant Formulas

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02481531
Other study ID # 3387-1
Secondary ID
Status Completed
Phase N/A
First received June 19, 2015
Last updated March 24, 2017
Start date July 2015
Est. completion date December 15, 2016

Study information
Verified date March 2017
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 373
Est. completion date December 15, 2016
Est. primary completion date December 15, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 14 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Previously marketed infant formula

• Previously marketed formula using a similar protein

Locations
Country Name City State
United States Children's Research, LLC Altamonte Springs Florida
United States Heartland Research Associates, LLC Augusta Kansas
United States Kentucky Pediatrics/Adult Research Bardstown Kentucky
United States Birmingham Pediatric Associates Birmingham Alabama
United States Coastal Pediatric Research Charleston South Carolina
United States Pediatric Associates of Mt. Carmel, Inc Cincinnati Ohio
United States Ohio Pediatric Research Association Dayton Ohio
United States Southeastern Pediatric Associates Dothan Alabama
United States Deaconess Clinical Research Evansville Indiana
United States Pediatric Associates of Fairfield, Inc. Fairfield Ohio
United States Northwest Arkansas Pediatric Clinic Fayetteville Arkansas
United States The Jackson Clinic - North Jackson Jackson Tennessee
United States The Children's Clinic of Jonesboro, P.A. Jonesboro Arkansas
United States Holston Medical Group Kingsport Tennessee
United States DCOL Center for Clinical Research Longview Texas
United States Heartland Research Associates, LLC Newton Kansas
United States Norwich Pediatric Group, P.C. Norwich Connecticut
United States Owensboro Pediatrics Owensboro Kentucky
United States Pediatrics East - Alabama Clinical Therapeutics Pinson Alabama
United States UHMP Comprehensive Pediatrics Westlake Ohio
United States Heartland Research Associates, LLC Wichita Kansas
United States Woburn Pediatic Associates Woburn Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body weight measured at each study visit Measurement collected with a calibrated infant scale 12 months
Secondary Body length measured at each study visit Measurement collected with a standardized length board 12 months
Secondary Head circumference measured at each study visit Measurement collected with a standardized measuring tape 12 months
Secondary Parental recall of study formula intake at each study visit 12 months
Secondary Parental recall of stool consistency measured at each study visit 12 months
Secondary Blood Collection Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein Once at 12 months
Secondary Medically-confirmed adverse events collected throughout the study period 12 months
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