Fatty Acids in Neurological Development of Formula Fed Infants - Full Text View

Purpose

The purpose of this study is to continue work on the role of long chain polyunsaturated fatty acids (LCPUFA)on neurological development in infants supplemented with formula with this type of fatty acids and/or breast milk.

Condition	Intervention	Phase
Normality	Procedure: adding Nutrient Fatty acids (LCPUFA) to formula	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Fatty Acids in Neurological Development of Formula Fed Infants

Further study details as provided by University of Kansas:

Primary Outcome Measures:

visual acuity [ Time Frame: 6 weeks, 4 month, 6 month, 9 month, 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

infant development [ Time Frame: 4 month, 6 month, 9 month, 1 year, 18 month ] [ Designated as safety issue: Yes ]

Enrollment:	170
Study Start Date:	September 2003
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Milk based formula with 0.32% DHA and 0.64% ARA	Procedure: adding Nutrient Fatty acids (LCPUFA) to formula variable amounts of DHA
2: Experimental Milk based formula with 0.64% DHA and 0.64 ARA	Procedure: adding Nutrient Fatty acids (LCPUFA) to formula variable amounts of DHA
3: Experimental Milk based formula with 0.96% DHA and 0.64% ARA	Procedure: adding Nutrient Fatty acids (LCPUFA) to formula variable amounts of DHA
4: No Intervention Milk based formula without DHA or ARA

Detailed Description:

Early work has shown that infants fed formula supplemented with long chair polyunsaturated fatty acids had visual acuity similar to breast fed babies. This study continues this work by feeding formula with LCPUFA for 12 months and examining neurological outcomes at 12 & 18 months using developmental tests.

Eligibility

Ages Eligible for Study:	up to 9 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy term infants

Exclusion Criteria:

not breast fed infants
low birth weight
large birth weight

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222157

Locations


United States, Kansas
	University of Kansas Medical Center
	Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

Mead Johnson

Investigators


Principal Investigator:	Susan E. Carlson, PhD	University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Susan E. Carlson, PhD )
Study ID Numbers:	9198
First Received:	September 13, 2005
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00222157
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	University of Kansas Mead Johnson
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00222157