DHA Supplementation and Pregnancy Outcome

February 11, 2016 updated by: Susan Carlson, PhD

Kansas University DHA Outcome Study (KUDOS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DHA capsules
Drug: DHA
600 mg DHA
Other Names:
  • docosahexaenoic acid
Placebo Comparator: Placebo capsules
Placebo capsule
Other: Placebo capsule
Placebo capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Susan Carlson, PhD

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Susan E Carlson, PhD, University of Kansas Medical Center
  • Principal Investigator: John Colombo, PhD, University of Kansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 15, 2005

First Submitted That Met QC Criteria

December 16, 2005

First Posted (Estimate)

December 19, 2005

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 10186 (Other Identifier: CTEP)
  • R01HD047315 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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