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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00712608
Other study ID # 3378-2
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02646969 - Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life N/A
Terminated NCT01137877 - Growth and Tolerance of Healthy Term Infants to a New Infant Formula Phase 3
Completed NCT01155414 - Tolerance of Healthy Term Infants Fed Infant Formulas #4 Phase 3
Completed NCT04015050 - Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants. N/A
Completed NCT01497314 - Growth and Safety of a Low Lactose Milk-Based Infant Formula N/A
Terminated NCT02221687 - The Combiotic-Study N/A