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

NCT01353807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 533

Last updated 2014-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Preterm Delivery
  • Atopy
  • Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

Fish oil

4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids

DIETARY_SUPPLEMENT

Olive oil

4 1-g gelatine capsules with virgin olive oil

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • The Danish Council for Strategic Research

    collaborator OTHER
  • Danish Council for Independent Research

    collaborator OTHER
  • Lundbech Foundation

    collaborator UNKNOWN
  • EU Commision, DG12

    collaborator UNKNOWN
  • Centre for Fetal Programming, Denmark

    lead OTHER

Principal Investigators

  • Sjurdur F. Olsen, MD · Statens Serum Institut

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1989-11-30
Primary Completion
1990-12-31
Completion
2011-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01353807 on ClinicalTrials.gov