Fish Oil Supplementation to Pregnant Women in China (FOPCHIN)

May 11, 2016 updated by: Centre for Fetal Programming, Denmark

Fish Oil Supplementation to Prevent Preterm Delivery in China: A Randomized Controlled Trial

This randomized controlled trial with fish oil supplementation to pregnant women conducted in areas of China, which are generally low in fish intake and low income, aims at answering the following primary questions:

  • Is a dose of 2.0 g/d long chain n-3 fatty acids efficient in preventing preterm birth
  • Is a dose of 0.5 g/d long chain n-3 fatty acids efficient in preventing preterm birth
  • Is a dose of 0.5 g/d as efficient as a dose of 2.0 g/d in affecting timing of spontaneous delivery in the preterm period

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The basic design is that of a randomized controlled trial with three groups randomized in ratios of 1:1:1. Two different doses of long chain n-3 fatty acids are tested against zero grams long chain n-3 fatty acids (lc-n3FA). These are provided in similarly looking gelatine capsules with either fish oil, a mixture (1:3) of fish oil and olive oil, or olive oil. Eligible women are randomized at around gestation weeks 16-24 and are asked to take the capsules until they have completed the preterm period (i.e. at 37 full gestation weeks) or until they deliver. Women are asked to complete questionnaires at randomization about diet and other baseline information, and again in gestation week 30 and after delivery. The trial is undertaken at hospitals in the two provinces of Gan-Su and Shaanxi. The three randomization groups will be compared with respect to proportions of preterm delivery. Cox regression will be used to compare the groups with respect to rates of spontaneous deliveries while accounting for elective delivery by regarding these as censoring events.

Study Type

Interventional

Enrollment (Actual)

5531

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

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pregnancy without known complications

Exclusion Criteria:

  • Regular user of fish oil
  • Regular user of NSAIDs
  • Known twin 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose fish oil
Women will be offered 4 capsules per day containing fish oil
Dietary supplement: High dose fish oil
Four 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA
Experimental: Low dose fish oil
Women will be offered 4 capsules per day containing mixed fish oil and olive oil
Dietary supplement: Low dose fish oil
Four 0.72-gram gelatine capsules per day with a mixture of fish oil and olive oil providing 0.5 g/d lc-n3FA
Placebo Comparator: Control
Women will be offered 4 capsules per day containing olive oil
Dietary supplement: Olive oil
Four 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature birth
Time Frame: 20 weeks on average, from randomization at gestation weeks 16-24 until on average gestation week 40
Delivery occurring earlier than 259 gestation days
20 weeks on average, from randomization at gestation weeks 16-24 until on average gestation week 40

Collaborators and Investigators

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

Sponsor

Centre for Fetal Programming, Denmark

Collaborators

Shanghai Institute of Planned Parenthood Research

Investigators

  • Study Director: Sjurdur F Olsen, Ph.D., Statens Serum Institut
  • Principal Investigator: Weijin Zhou, Ph.D., Shanghai Institute of Planned Parenthood Research

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

March 1, 2008

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #6-FY01-317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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