Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP') (FOTIP)

August 29, 2014 updated by: Sjurdur Frodi Olsen

Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies

The initial trial examined if fish oil supplementation during pregnancy could reduce the risk of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in pregnancies that were at increased risk of these complications. The study was designed as a multi-centre clinical trial based in 19 hospitals in seven countries in Europe.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1619

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • There were six subgroups with different inclusion criteria:
  • The low dose (prophylactic) section enrolled women who after 16 weeks of gestation had been identified with an uncomplicated pregnancy, who in an earlier pregnancy had experienced preterm delivery (this was subgroup 1)
  • Intrauterine growth retardation (subgroup 2) or pregnancy induced hypertension (subgroup 3)
  • Women who had been identified with twin pregnancies (subgroup 4)
  • The high dose ('therapeutic') section enrolled women with threatening pre-eclampsia (subgroup 5) or suspected intrauterine growth retardation in the current pregnancy (subgroup 6).

Exclusion Criteria:

  • Diabetes mellitus in or before pregnancy
  • Diagnosed severe fetal malformation or hydrops in current pregnancy
  • Suspicion in current pregnancy, or occurrence in an earlier pregnancy, of placental abruption
  • Drug or alcohol abuse
  • Regular intake of fish oil or of non-steroidal antiinflammatory agents or other drugs with an effect on thombocyte function or eicosanoid metabolism
  • Allergy to fish products.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low dose fish oil
Dietary supplement: Low dose fish oil
Four 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 2.7 g n-3 fatty acids per day.
Other Names:
  • Pikasol
Placebo Comparator: Low dose olive oil
Dietary supplement: Low dose olive oil
Four 1 g capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
Experimental: High dose fish oil
Dietary supplement: High dose fish oil
Nine 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 6.1 g n-3 fatty acids per day.
Other Names:
  • Pikasol
Placebo Comparator: High dose olive oil
Dietary supplement: High dose olive oil
Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Induced Hypertension
Time Frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest
Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
Intrauterine growth retardation
Time Frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
Birth weight below the 10th centile, as assessed from the infant's birth weight, gestational age and gender, on the basis of Danish standards (Br J Obstet Gynaecol 1986; 93: 128-134; and Acta Obstet Gynecol Scand 1985; 64: 65-70).
Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
Preterm delivery
Time Frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
Delivery at an estimated gestational age of less than 259 days (37 completed weeks)
Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.

Collaborators and Investigators

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

Sponsor

Sjurdur Frodi Olsen

Collaborators

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Niels J Secher, Professor, Rigshospitalet, Denmark
  • Principal Investigator: Sjurdur F Olsen, Professor, Center for Fetal Programming, Denmark

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, 1990

Primary Completion (Actual)

January 1, 1996

Study Completion (Actual)

December 1, 1999

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DT2006-41-6257

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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