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

NCT02229526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1619

Last updated 2014-09-01

No results posted yet for this study

Summary

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.

Conditions

  • Preterm Birth
  • Intrauterine Growth Retardation
  • Pregnancy Induced Hypertension

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Sjurdur Frodi Olsen

    lead OTHER

Principal Investigators

  • Niels J Secher, Professor · Rigshospitalet, Denmark

  • Sjurdur F Olsen, Professor · Center for Fetal Programming, Denmark

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1990-01-31
Primary Completion
1996-01-31
Completion
1999-12-31

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Entities

Diseases

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 NCT02229526 on ClinicalTrials.gov