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Fish Oil Supplementation to Pregnant Women in China

NCT02770456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5531

Last updated 2016-05-12

No results posted yet for this study

Summary

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

Conditions

  • Premature Birth

Interventions

DIETARY_SUPPLEMENT

High dose fish oil

Four 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA

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

DIETARY_SUPPLEMENT

Olive oil

Four 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA

Sponsors & Collaborators

  • Shanghai Institute of Planned Parenthood Research

    collaborator OTHER_GOV

  • Centre for Fetal Programming, Denmark

    lead OTHER

Principal Investigators

  • Sjurdur F Olsen, Ph.D. · Statens Serum Institut

  • Weijin Zhou, Ph.D. · Shanghai Institute of Planned Parenthood Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2015-12-31
Completion
2016-04-30

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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 NCT02770456 on ClinicalTrials.gov