The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.

Condition	Intervention	Phase
Pregnancy	Procedure: Docosahexaenoic acid or DHA	Phase III

Further study details as provided by University of Kansas:

Primary Outcomes: Gestation duration, birth weight, length and head circumference, infant and child visual acuity, Stereoacuity, attention, problem solving, memory, global development, distractibility
Secondary Outcomes: Infant growth throughout infancy and toddlerhood
Expected Total Enrollment:  350

Although numerous trials show benefits of postnatal DHA supplementation for visual acuity and others show benefits for cognitive function and/or attention, studies of increased DHA exposure during fetal life are needed, especially in the US. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.

Ages Eligible for Study:  16 Years   -   36 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Pregnant 8-14 wks at enrollment
• single fetus
• BMI <40

Exclusion:

• diabetes (Type I, ii, GDM)
• hypertension (primary, PIH, preeclampsia/eclampsia)

Please refer to this study by ClinicalTrials.gov identifier  NCT00266825

Susan E Carlson, PhD      (913) 588-5359    scarlson@kumc.edu

Kansas
      University of Kansas Medical Center, Kansas City,  Kansas,  66160,  United States
Missouri
      Truman Medical Center, Kansas City,  Missouri,  64108,  United States

Study chairs or principal investigators

Susan E Carlson, PhD,  Principal Investigator,  University of Kansas   
John Colombo, PhD,  Principal Investigator,  University of Kansas   

Study ID Numbers:  10186; R01 HD047315
Last Updated:  December 16, 2005
Record first received:  December 15, 2005
ClinicalTrials.gov Identifier:  NCT00266825
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10