The Evaluation of Cow Milk-Based Formulas

Term Infants Clinical Trial

Official title:

The Evaluation of Cow Milk-Based Formulas - Study A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518414
• Other study ID #: 3378
• Status: Completed
• Phase: N/A
• First received: August 17, 2007
• Last updated: September 24, 2015
• Start date: April 2007
• Est. completion date: January 2008

Study information

• Verified date: September 2015
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 18 Days

Eligibility

Inclusion Criteria:

• Healthy, term infant

• 10 to 18 days of age

Exclusion Criteria:

• Breast fed infants

• Infants with formula intolerance

Study Design

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

Related Conditions & MeSH terms

• Term Infants

Intervention

Other:
• Marketed infant formula with DHA and ARA

• Milk-based infant formula with DHA and ARA

• Milk-based formula with DHA, ARA, prebiotics

Locations

Country	Name	City	State
United States	Birmingham Pediatric Group	Birmingham	Alabama
United States	Southlake Pediatrics	Birmingham	Alabama
United States	Welborn Clinic	Evansville	Indiana
United States	Holston Medical Group	Kingsport	Tennessee
United States	Arkansas Pediatric Clinic	Little Rock	Arkansas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	The Center for Human Nutrition	Omaha	Nebraska
United States	Children's Medical Association	Tamarac	Florida
United States	Northwood Pediatrics	The Woodlands	Texas

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	Red Blood Cell (RBC) ARA and DHA		120 Days of age	No
Secondary	Phospholipid fatty acids, tolerance		120 Days of age	No