The Evaluation of Cow's Milk Formula - Study B

Not Applicable

Completed

• Conditions: Healthy Term Infants
• Interventions: Other: Infant formula; Other: Cow's milk infant formula

• Registration Number: NCT00712608
• Lead Sponsor: Mead Johnson Nutrition

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-10
• Study Start: 2008-08
• Status Verified: 2009-04
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2010-01-26
• Last Update Posted: 2010-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Infant formula	Marketed cow's milk-based formula
2	Infant formula	Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
3	Cow's milk infant formula	Cow's milk based formula with prebiotic, different level of fatty acids and fat and a different calcium source

Primary Outcome Measures

Name	Time	Method
Rate of weight gain	106 days

Secondary Outcome Measures

Name	Time	Method
length and head circumference	106 days

Trial Locations

Locations (21)

Central Arkansas Pediatric Clinic; 🇺🇸 Benton, Arkansas, United States

Medical Associates; 🇺🇸 Fayetteville, Arkansas, United States

Odyssey Research; 🇺🇸 Minot, North Dakota, United States

Birmingham Pediatric Group; 🇺🇸 Birmingham, Alabama, United States

Red Lion Pediatrics; 🇺🇸 Philadelphia, Pennsylvania, United States

Alabama Clinical Therapeutics; 🇺🇸 Dothan, Alabama, United States

Palm Beach Clinical Investigation, LLC; 🇺🇸 West Palm Beach, Florida, United States

Primary Physicians Research, Inc; 🇺🇸 Pittsburgh, Pennsylvania, United States

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States

Holston Medical Group, MeadowView Lane; 🇺🇸 Kingsport, Tennessee, United States

Arkansas Pediatric Clinic; 🇺🇸 Little Rock, Arkansas, United States

Welborn Clinic Research; 🇺🇸 Newburgh, Indiana, United States

Woburn Pediatric Associates Research Department; 🇺🇸 Woburn, Massachusetts, United States

The Center for Human Nutrition; 🇺🇸 Omaha, Nebraska, United States

Aspen Medical Group; 🇺🇸 St. Paul, Minnesota, United States

Southwestern Medical Clinic, PC; 🇺🇸 Stevensville, Michigan, United States

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States

Holston Medical Group; 🇺🇸 Kingsport, Tennessee, United States

DCOL Center for Clinical Research; 🇺🇸 Longview, Texas, United States

Arkansas Children's Hospital Research Institute; 🇺🇸 Little Rock, Arkansas, United States

Norwich Pediatric Group, PC; 🇺🇸 Norwich, Connecticut, United States