Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health

February 27, 2014 updated by: Centre for Fetal Programming, Denmark
The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant women, while they were in gestational week 30, were randomized to fish oil supplements providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no supplements; they were asked to take the supplements until delivery. Health outcomes were assessed during pregnancy and delivery. Further, offspring health and development has been examined during the ensuring two decades by making linkages to the rich Danish health and administrative registries, by asking the offspring to complete web-based questionnaires, and by examining the offspring physically.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

533

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

  • Denmark
      • Aarhus, Denmark, DK-8000
        • Aarhus University Hospital

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy pregnant women in gestation week 30

Exclusion Criteria:

  • Bleeding episodes during pregnancy

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fish oil supplementation
These women received 4 1-g capsules of fish oil per day providing 2,7 grams long chain n-3 fatty acids per day, from gestation week 30 until delivery
Dietary supplement: Fish oil
4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids
Other Names:
  • Pikasol
Placebo Comparator: Olive oil
These women received 4 1-g capsules with olive oil per day from gestational week 30 until delivery
Dietary supplement: Olive oil
4 1-g gelatine capsules with virgin olive oil
No Intervention: No oil supplement
These women received no capsules with oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestation length
Time Frame: 1989-1990 (1 year)
We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery
1989-1990 (1 year)

Collaborators and Investigators

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

Sponsor

Centre for Fetal Programming, Denmark

Collaborators

National Institutes of Health (NIH)
Danish Council for Independent Research
The Danish Council for Strategic Research
Lundbech Foundation
EU Commision, DG12

Investigators

  • Principal Investigator: Sjurdur F. Olsen, MD, Statens Serum Institut

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

November 1, 1989

Primary Completion (Actual)

December 1, 1990

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (Estimate)

May 16, 2011

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-AA-20060182
  • R21AT004603 (U.S. NIH Grant/Contract)

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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