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

Mead Johnson Nutrition

Status: Completed

Conditions: Growth

Treatments: Other: Previously marketed formula using a similar protein; Other: Previously marketed infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02481531

3387-1

Details and patient eligibility

About

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.

Enrollment: 373 patients

Sex: All

Ages: 10 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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373 participants in 2 patient groups

Previously marketed infant formula

Active Comparator group

Description:

Cow's milk-based infant formula

Treatment:

Other: Previously marketed infant formula

Previously marketed formula using a similar protein

Experimental group

Description:

Cow's milk-based infant formula

Treatment:

Other: Previously marketed formula using a similar protein