DHA Supplementation and Pregnancy Outcome

Phase 3

Completed

• Conditions: Pregnancy
• Interventions: Drug: DHA; Other: Placebo capsule

• Registration Number: NCT00266825
• Lead Sponsor: Susan Carlson, PhD

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2005-12-15
• Study First Submitted QC: 2005-12-16
• Study First Posted: 2005-12-19
• Study Start: 2006-01
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2015-06-30
• Results First Submitted QC: 2016-01-05
• Status Verified: 2016-02
• Results First Posted: 2016-02-04
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA capsules	DHA	DHA capsules
Placebo capsules	Placebo capsule	Placebo capsule

Primary Outcome Measures

Name	Time	Method
Gestational Age	at time of birth	Gestational age of babies at time of birth in days
Percentage of Total Fatty Acids by Weight	at time of birth	Measure of RBC-phospholipid-DHA at Birth
Birth Weight	at time of birth	Weight of baby at birth
Birth Length	at time of birth	Length of baby at birth

Secondary Outcome Measures

Name	Time	Method
Gender of Babies	at time of birth
Ponderal Index	at time of birth	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.
Cord RBC-phospholipid-DHA	at time of birth	Percentage of total fatty acids by weight in cord RBC
Head Circumference	at time of birth	Measure of circumference of baby's head in centimeters at time of birth.
Preterm Births	births before week 37 of gestation	Percentage of births occurring at less than 37 weeks of gestation.

Trial Locations

Locations (2)

Truman Medical Center; 🇺🇸 Kansas City, Missouri, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States