DHA Supplementation and Pregnancy Outcome

Pregnancy Clinical Trial

Official title:

Kansas University DHA Outcome Study (KUDOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266825
• Other study ID #: 10186
• Secondary ID: R01HD047315
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2005
• Last updated: February 11, 2016
• Start date: January 2006
• Est. completion date: October 2011

Study information

• Verified date: February 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 36 Years

Eligibility

Inclusion Criteria:

• Pregnant 8-20 wks at enrollment

• single fetus

• BMI <40

Exclusion Criteria:

• diabetes (Type I, ii, GDM)

• hypertension (primary, PIH, preeclampsia/eclampsia)

Study Design

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• DHA
600 mg DHA

Other:
• Placebo capsule
Placebo capsule

Locations

Country	Name	City	State
United States	Truman Medical Center	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Susan Carlson, PhD	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Carlson SE, Colombo J, Gajewski BJ, Gustafson KM, Mundy D, Yeast J, Georgieff MK, Markley LA, Kerling EH, Shaddy DJ. DHA supplementation and pregnancy outcomes. Am J Clin Nutr. 2013 Apr;97(4):808-15. doi: 10.3945/ajcn.112.050021. Epub 2013 Feb 20. — View Citation

Ozias MK, Kerling EH, Christifano DN, Scholtz SA, Colombo J, Carlson SE. Typical prenatal vitamin D supplement intake does not prevent decrease of plasma 25-hydroxyvitamin D at birth. J Am Coll Nutr. 2014;33(5):394-9. doi: 10.1080/07315724.2013.879843. Ep — View Citation

Scholtz SA, Kerling EH, Shaddy DJ, Li S, Thodosoff JM, Colombo J, Carlson SE. Docosahexaenoic acid (DHA) supplementation in pregnancy differentially modulates arachidonic acid and DHA status across FADS genotypes in pregnancy. Prostaglandins Leukot Essent — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Total Fatty Acids by Weight	Measure of RBC-phospholipid-DHA at Birth	at time of birth	No
Primary	Gestational Age	Gestational age of babies at time of birth in days	at time of birth	No
Primary	Birth Weight	Weight of baby at birth	at time of birth	No
Primary	Birth Length	Length of baby at birth	at time of birth	No
Secondary	Ponderal Index	Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics.	at time of birth	No
Secondary	Gender of Babies		at time of birth	No
Secondary	Cord RBC-phospholipid-DHA	Percentage of total fatty acids by weight in cord RBC	at time of birth	No
Secondary	Head Circumference	Measure of circumference of baby's head in centimeters at time of birth.	at time of birth	No
Secondary	Preterm Births	Percentage of births occurring at less than 37 weeks of gestation.	births before week 37 of gestation	No