Clinical trial NCT02770456: Fish Oil Supplementation to Pregnant Women in China
Official title: Fish Oil Supplementation to Prevent Preterm Delivery in China: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: fish oil, preterm birth, pregnancy, China, prevention
Lead sponsor: Centre for Fetal Programming, Denmark
Sponsor class: OTHER
Collaborators: name: Shanghai Institute of Planned Parenthood Research
First posted: 2016-05-12
Enrollment: 5531
Sex: ALL
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: Inclusion Criteria:

* Pregnancy without known complications

Exclusion Criteria:

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

Primary outcomes:
measure: Premature birth
timeFrame: 20 weeks on average, from randomization at gestation weeks 16-24 until on average gestation week 40
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Statens Serum Institut
name: Sjurdur F Olsen, Ph.D.
role: STUDY_DIRECTOR
affiliation: Shanghai Institute of Planned Parenthood Research
name: Weijin Zhou, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.