The Evaluation of Cow's Milk Formula - Study B

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00712608

Enrollment

399

Registered

2008-07-10

Start date

2008-08-31

Completion date

2009-10-31

Last updated

2010-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Term Infants

Keywords

Term, Infant, Formula

Brief summary

A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and fat, or an experimental cow's milk formula with prebiotic + a different calcium source + a different level of fatty acids and fat

Interventions

OTHERInfant formula

Marketed cow's milk base infant formula 20 kcal/oz

OTHERCow's milk infant formula

Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Days to 16 Days

Healthy volunteers

Yes

Inclusion criteria

* Term infant * 12-16 days of age * 37-42 weeks GA

Exclusion criteria

* History of chronic disease, congenital malformation * Feeding difficulties or formula intolerance * LGA

Design outcomes

Primary

Measure	Time frame
Rate of weight gain	106 days

Secondary

Measure	Time frame
length and head circumference	106 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026