Fish Oil Supplementation to Pregnant Women in China

Premature Birth Clinical Trial

— FOPCHIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770456
• Other study ID #: #6-FY01-317
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: May 11, 2016
• Start date: March 2008
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Centre for Fetal Programming, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5531
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 44 Years

Eligibility

Inclusion Criteria:

• Pregnancy without known complications

Exclusion Criteria:

• Regular user of fish oil

• Regular user of NSAIDs

• Known twin pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth

Intervention

Dietary Supplement:
• High dose fish oil
Four 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA
• 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
• Olive oil
Four 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Fetal Programming, Denmark	Shanghai Institute of Planned Parenthood Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature birth	Delivery occurring earlier than 259 gestation days	20 weeks on average, from randomization at gestation weeks 16-24 until on average gestation week 40	No