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Fish Oil Supplementation to Pregnant Women in China (FOPCHIN)

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ClinicalTrials.gov Identifier: NCT02770456
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Shanghai Institute of Planned Parenthood Research
Information provided by (Responsible Party):
Centre for Fetal Programming, Denmark

Brief 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

Condition or disease Intervention/treatment Phase
Premature Birth Dietary Supplement: High dose fish oil Dietary Supplement: Low dose fish oil Dietary Supplement: Olive oil Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5531 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Fish Oil Supplementation to Prevent Preterm Delivery in China: A Randomized Controlled Trial
Study Start Date : March 2008
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnancy without known complications

Exclusion Criteria:

  • Regular user of fish oil
  • Regular user of NSAIDs
  • Known twin pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770456


Sponsors and Collaborators
Centre for Fetal Programming, Denmark
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

Responsible Party: Centre for Fetal Programming, Denmark
ClinicalTrials.gov Identifier: NCT02770456     History of Changes
Other Study ID Numbers: #6-FY01-317
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Centre for Fetal Programming, Denmark:
fish oil, preterm birth, pregnancy, China, prevention

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications