Fish Oil Supplementation to Pregnant Women in China

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Premature Birth

Intervention / Treatment
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* Dietary Supplement: High dose fish oil
* Dietary Supplement: Low dose fish oil
* Dietary Supplement: Olive oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnancy without known complications Exclusion Criteria: Regular user of fish oil Regular user of NSAIDs Known twin pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fish oil, preterm birth, pregnancy, China, prevention