Overview

This trial is active, not recruiting.

Condition growth
Treatments previously marketed infant formula, previously marketed formula using a similar protein
Sponsor Mead Johnson Nutrition
Start date July 2015
End date January 2017
Trial size 373 participants
Trial identifier NCT02481531, 3387-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Active Comparator)
Cow's milk-based infant formula
previously marketed infant formula
(Experimental)
Cow's milk-based infant formula
previously marketed formula using a similar protein

Primary Outcomes

Measure
Body weight measured at each study visit
time frame: 12 months

Secondary Outcomes

Measure
Body length measured at each study visit
time frame: 12 months
Head circumference measured at each study visit
time frame: 12 months
Parental recall of study formula intake at each study visit
time frame: 12 months
Parental recall of stool consistency measured at each study visit
time frame: 12 months
Blood Collection
time frame: Once at 12 months
Medically-confirmed adverse events collected throughout the study period
time frame: 12 months

Eligibility Criteria

Male or female participants up to 14 days old.

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

Additional Information

Official title Growth and Tolerance of Cow's Milk-Based Infant Formulas
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Mead Johnson Nutrition.