The Evaluation of Cow's Milk Formula - Study B

Healthy Term Infants Clinical Trial

Official title:

The Evaluation of Cow's Milk Formula - Study B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712608
• Other study ID #: 3378-2
• Status: Completed
• Phase: N/A
• First received: July 8, 2008
• Last updated: January 26, 2010
• Start date: August 2008
• Est. completion date: October 2009

Study information

• Verified date: April 2009
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Term Infants

Intervention

Other:
• Infant formula
Marketed cow's milk base infant formula 20 kcal/oz
• Infant formula
cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source
• Cow's milk infant formula
Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source

Locations

Country	Name	City	State
United States	Central Arkansas Pediatric Clinic	Benton	Arkansas
United States	Birmingham Pediatric Group	Birmingham	Alabama
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Alabama Clinical Therapeutics	Dothan	Alabama
United States	Medical Associates	Fayetteville	Arkansas
United States	Holston Medical Group	Kingsport	Tennessee
United States	Holston Medical Group, MeadowView Lane	Kingsport	Tennessee
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas
United States	Arkansas Pediatric Clinic	Little Rock	Arkansas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	Odyssey Research	Minot	North Dakota
United States	Welborn Clinic Research	Newburgh	Indiana
United States	Southwestern Medical Clinic, PC	Niles	Michigan
United States	Norwich Pediatric Group, PC	Norwich	Connecticut
United States	The Center for Human Nutrition	Omaha	Nebraska
United States	Red Lion Pediatrics	Philadelphia	Pennsylvania
United States	Primary Physicians Research, Inc	Pittsburgh	Pennsylvania
United States	Aspen Medical Group	St. Paul	Minnesota
United States	Southwestern Medical Clinic, PC	Stevensville	Michigan
United States	Palm Beach Clinical Investigation, LLC	West Palm Beach	Florida
United States	Woburn Pediatric Associates Research Department	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	Rate of weight gain		106 days	Yes
Secondary	length and head circumference		106 days	Yes