DHA Supplementation and Pregnancy Outcome

August 15, 2014 updated by: Colorado State University

Maternal DHA Supplementation and Pregnancy Outcome

Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a trial of supplementation with DHA during pregnancy to increase gestational length. Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data were collected and infants growth at 2 and 4 months and cognitive development at 4 months and 1 year were measured.

Study Type

Interventional

Enrollment (Actual)

871

Phase

  • Not Applicable

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
    • Colorado
      • Denver, Colorado, United States, 80237
        • Denver Health Hospitals and Clinics
      • Fort Collins, Colorado, United States, 80523
        • Colorado State University

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnancy
  • 18 years of age or older

Exclusion Criteria:

  • cervical incompetence
  • presence of cervical cerclage
  • placenta previa
  • intrauterine infection
  • known substance abuse
  • multiple fetuses
  • current pre-eclampsia
  • preexisting diabetes

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 300 mg DHA
Dietary supplement: 300 mg DHA
Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding
Placebo Comparator: Placebo
olive oil or high oleic acid sunflower oil placebo
Dietary supplement: Placebo
Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period
Experimental: 600 mg DHA
Dietary supplement: 600 mg DHA
Pregnant women were given 600 mg DHA in the last trimester of pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational Length
Time Frame: 13 weeks
Length of gestation as measured by Last menstrual period method and US
13 weeks
Cognitive Development
Time Frame: 4 months
Bayley's Scales of Infant Development measured at 4 months of age
4 months
Cognitive Development
Time Frame: 12 months
Bayley's Scales of Infant Development measured at 12 months of age
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant birth length
Time Frame: 13 weeks
self-explanatory
13 weeks
Infant Growth Velocity
Time Frame: 2 months to 4 months of age
Change in infant length and weight from 2 to 4 months of age
2 months to 4 months of age
Infant birth weight
Time Frame: 13 weeks
self-explanatory
13 weeks
Infant head circumference at birth
Time Frame: 13 weeks
self-explanatory
13 weeks

Collaborators and Investigators

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

Sponsor

Colorado State University

Collaborators

USDA Beltsville Human Nutrition Research Center

Investigators

  • Principal Investigator: Mary A Harris, PhD, Colorado State University

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, 2001

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00186H

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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