Premature BirthFOPCHINNCT02770456
Fish Oil Supplementation to Pregnant Women in China
A study testing High dose fish oil, Low dose fish oil and Olive oil in people with Premature Birth, run by Centre for Fetal Programming, Denmark.
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… Read more about this study
- Who is it for?
- Ages 20 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- High dose fish oil, Low dose fish oil and Olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,531 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy without known complications
Who cannot join
- Regular user of fish oil
- Regular user of NSAIDs
- Known twin pregnancy
About this study
Official title: Fish Oil Supplementation to Prevent Preterm Delivery in China: A Randomized Controlled Trial
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
Read the 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.
- Conditions
- Premature Birth
- Being tested
- High dose fish oil, Low dose fish oil, Olive oil
- Keywords
- fish oil, preterm birth, pregnancy, China, prevention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose fish oilDietary supplement
Four 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA
Low dose fish oilDietary 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
Olive oilDietary supplement
Four 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA
| Study group | Role | What they receive |
|---|---|---|
| High dose fish oil | Experimental | Women will be offered 4 capsules per day containing fish oil Receives: 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 Receives: Dietary Supplement: Low dose fish oil |
| Control | Placebo comparator | Women will be offered 4 capsules per day containing olive oil Receives: Dietary Supplement: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature birth
Delivery occurring earlier than 259 gestation days
Measured: 20 weeks on average, from randomization at gestation weeks 16-24 until on average gestation week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMar 2008
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5,531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Fetal Programming, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Institute of Planned Parenthood Research
- Responsible party
- Sponsor
- Investigators
- Sjurdur F Olsen, Ph.D., Study director, Statens Serum InstitutWeijin Zhou, Ph.D., Principal investigator, Shanghai Institute of Planned Parenthood Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770456
- Sponsor's protocol ID
- #6-FY01-317
- Acronym
- FOPCHIN
- Status last verified
- May 2016
- First submitted
- 11 May 2016
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31387119
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil Supplementation to Prevent Preterm Delivery in China: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02770456
- Acronym / sponsor ID
- FOPCHIN / #6-FY01-317
- Conditions
- Premature Birth
- Keywords
- fish oil, preterm birth, pregnancy, China, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,531 participants (actual)
- Lead sponsor
- Centre for Fetal Programming, DenmarkUniversity, hospital or other
- Collaborators
- Shanghai Institute of Planned Parenthood Research
- Study start
- Mar 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose fish oil | Experimental | Dietary Supplement: High dose fish oilWomen will be offered 4 capsules per day containing fish oil |
| Low dose fish oil | Experimental | Dietary Supplement: Low dose fish oilWomen will be offered 4 capsules per day containing mixed fish oil and olive oil |
| Control | Placebo comparator | Dietary Supplement: Olive oilWomen will be offered 4 capsules per day containing olive oil |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnancy without known complications
Key exclusion criteria (3 listed)
- Regular user of fish oil
- Regular user of NSAIDs
- Known twin pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose fish oilFour 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA | Dietary supplement | High dose fish oil |
| Low dose fish oilFour 0.72-gram gelatine capsules per day with a mixture of fish oil and olive oil providing 0.5 g/d lc-n3FA | Dietary supplement | Low dose fish oil |
| Olive oilFour 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA | Dietary supplement | Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Derived from this study: PubMed 31387119Olsen 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sjurdur F Olsen, Ph.D. study director
Statens Serum Institut
Weijin Zhou, Ph.D. principal investigator
Shanghai Institute of Planned Parenthood Research
Questions about this trial
What is this clinical trial studying?
A study testing High dose fish oil, Low dose fish oil and Olive oil in people with Premature Birth, run by Centre for Fetal Programming, Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature birth (time frame: 20 weeks on average, from randomization at gestation weeks 16-24 until on average gestation week 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.