Fish Oil Supplementation to Pregnant Women in China

NCT02770456 | Completed

• 1 other identifier: #6-FY01-317
• Study Type: interventional
• Target: 5,531
• Locations: 0 countries
• Sites: N/A

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

Conditions

Premature Birth

Keywords

fish oil, preterm birth, pregnancy, China, prevention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

High dose fish oil

EXPERIMENTAL

Women will be offered 4 capsules per day containing fish oil

Dietary Supplement: High dose fish oil

Low dose fish oil

EXPERIMENTAL

Women will be offered 4 capsules per day containing mixed fish oil and olive oil

Dietary Supplement: Low dose fish oil

Control

PLACEBO COMPARATOR

Women will be offered 4 capsules per day containing olive oil

Dietary Supplement: Olive oil

Interventions

High dose fish oil DIETARY_SUPPLEMENT

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

High dose fish oil

Low dose fish oil DIETARY_SUPPLEMENT

Four 0.72-gram gelatine capsules per day with a mixture of fish oil and olive oil providing 0.5 g/d lc-n3FA

Low dose fish oil

Olive oil DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnancy without known complications

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Fetal Programming, Denmark: lead
• Shanghai Institute of Planned Parenthood Research: collaborator

Related Publications (1)

• Olsen SF, Halldorsson TI, Li M, Strom M, Mao Y, Che Y, Wang Y, Duan F, Olsen J, Zhou W. Examining the Effect of Fish Oil Supplementation in Chinese Pregnant Women on Gestation Duration and Risk of Preterm Delivery. J Nutr. 2019 Nov 1;149(11):1942-1951. doi: 10.1093/jn/nxz153.

  PMID: 31387119 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Fish Oils; Olive Oil

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sjurdur F Olsen, Ph.D.

  Statens Serum Institut

  STUDY DIRECTOR

• Weijin Zhou, Ph.D.

  Shanghai Institute of Planned Parenthood Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 12, 2016
• Study Start: March 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share