Preterm BirthFOTIPNCT02229526
Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')
A study testing Low dose fish oil, Low dose olive oil and High dose fish oil in people with Preterm Birth and Intrauterine Growth Retardation, run by Sjurdur Frodi Olsen.
Trial summary
The initial trial examined if fish oil supplementation during pregnancy could reduce the risk of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in pregnancies that were at increased risk of these complications. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Birth, Intrauterine Growth Retardation, Pregnancy Induced Hypertension
- What is being tested?
- Low dose fish oil, Low dose olive oil and High dose fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,619 participants
- Where
- No sites listed yet
- Study dates
- Jan 1990to Dec 1999
- 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 Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- There were six subgroups with different inclusion criteria:
- The low dose (prophylactic) section enrolled women who after 16 weeks of gestation had been identified with an uncomplicated pregnancy, who in an earlier pregnancy had experienced preterm delivery (this was subgroup 1)
- Intrauterine growth retardation (subgroup 2) or pregnancy induced hypertension (subgroup 3)
- Women who had been identified with twin pregnancies (subgroup 4)
- The high dose ('therapeutic') section enrolled women with threatening pre-eclampsia (subgroup 5) or suspected intrauterine growth retardation in the current pregnancy (subgroup 6).
Who cannot join
- Diabetes mellitus in or before pregnancy
- Diagnosed severe fetal malformation or hydrops in current pregnancy
- Suspicion in current pregnancy, or occurrence in an earlier pregnancy, of placental abruption
- Drug or alcohol abuse
- Regular intake of fish oil or of non-steroidal antiinflammatory agents or other drugs with an effect on thombocyte function or eicosanoid metabolism
- Allergy to fish products.
About this study
Official title: Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies
The initial trial examined if fish oil supplementation during pregnancy could reduce the risk of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in pregnancies that were at increased risk of these complications. The study was designed as a multi-centre clinical trial based in 19 hospitals in seven countries in Europe.
- Being tested
- Low dose fish oil, Low dose olive oil, High dose fish oil, High dose olive oil
- Keywords
- Fish oil supplementation, RCT, High risk pregnancies, Twin pregnancy, Preterm birth, Intrauterine growth retardation, Pregnancy induced hypertension
- Medical subject headings
- Premature Birth, Fetal Growth Retardation, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose fish oilDietary supplement
Also called Pikasol
Four 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 2.7 g n-3 fatty acids per day.
Low dose olive oilDietary supplement
Four 1 g capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
High dose fish oilDietary supplement
Also called Pikasol
Nine 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 6.1 g n-3 fatty acids per day.
High dose olive oilDietary supplement
Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
| Study group | Role | What they receive |
|---|---|---|
| Low dose fish oil | Active comparator | Not described Receives: Dietary Supplement: Low dose fish oil |
| Low dose olive oil | Placebo comparator | Not described Receives: Dietary Supplement: Low dose olive oil |
| High dose fish oil | Experimental | Not described Receives: Dietary Supplement: High dose fish oil |
| High dose olive oil | Placebo comparator | Not described Receives: Dietary Supplement: High dose olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Induced Hypertension
One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest
Measured: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
Intrauterine growth retardation
Birth weight below the 10th centile, as assessed from the infant's birth weight, gestational age and gender, on the basis of Danish standards (Br J Obstet Gynaecol 1986; 93: 128-134; and Acta Obstet Gynecol Scand 1985; 64: 65-70).
Measured: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
Preterm delivery
Delivery at an estimated gestational age of less than 259 days (37 completed weeks)
Measured: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startJan 1990
- Primary completionJan 1996
- Study completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,619 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sjurdur Frodi Olsen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Sjurdur Frodi Olsen, Centre for Fetal Programming, Denmark
- Investigators
- Niels J Secher, Professor, Principal investigator, Copenhagen University Hospital, RigshospitaletSjurdur F Olsen, Professor, Principal investigator, Center for Fetal Programming, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229526
- Sponsor's protocol ID
- DT2006-41-6257
- Acronym
- FOTIP
- Status last verified
- Aug 2014
- First submitted
- 3 Mar 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olsen SF, Secher NJ, Tabor A, Weber T, Walker JJ, Gluud C. Randomised clinical trials of fish oil supplementation in high risk pregnancies. Fish Oil Trials In Pregnancy (FOTIP) Team. BJOG. 2000 Mar;107(3):382-95. doi: 10.1111/j.1471-0528.2000.tb13235.x.
PubMed 10740336Olsen SF, Osterdal ML, Salvig JD, Weber T, Tabor A, Secher NJ. Duration of pregnancy in relation to fish oil supplementation and habitual fish intake: a randomised clinical trial with fish oil. Eur J Clin Nutr. 2007 Aug;61(8):976-85. doi: 10.1038/sj.ejcn.1602609. Epub 2007 Feb 7.
PubMed 17299499
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies
- ClinicalTrials.gov ID
- NCT02229526
- Acronym / sponsor ID
- FOTIP / DT2006-41-6257
- Keywords
- Fish oil supplementation, RCT, High risk pregnancies, Twin pregnancy, Preterm birth, Intrauterine growth retardation, Pregnancy induced hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,619 participants (actual)
- Lead sponsor
- Sjurdur Frodi OlsenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Jan 1990
- Primary completion
- Jan 1996 (actual)
- Study completion
- Dec 1999 (actual)
- First posted
- 1 Sep 2014 (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.
The initial trial examined if fish oil supplementation during pregnancy could reduce the risk of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in pregnancies that were at increased risk of these complications. The study was designed as a multi-centre clinical trial based in 19 hospitals in seven countries in Europe.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose fish oil | Active comparator | Dietary Supplement: Low dose fish oil |
| Low dose olive oil | Placebo comparator | Dietary Supplement: Low dose olive oil |
| High dose fish oil | Experimental | Dietary Supplement: High dose fish oil |
| High dose olive oil | Placebo comparator | Dietary Supplement: High dose olive oil |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- There were six subgroups with different inclusion criteria:
- The low dose (prophylactic) section enrolled women who after 16 weeks of gestation had been identified with an uncomplicated pregnancy, who in an earlier pregnancy had experienced preterm delivery (this was subgroup 1)
- Intrauterine growth retardation (subgroup 2) or pregnancy induced hypertension (subgroup 3)
- Women who had been identified with twin pregnancies (subgroup 4)
- The high dose ('therapeutic') section enrolled women with threatening pre-eclampsia (subgroup 5) or suspected intrauterine growth retardation in the current pregnancy (subgroup 6).
Key exclusion criteria (6 listed)
- Diabetes mellitus in or before pregnancy
- Diagnosed severe fetal malformation or hydrops in current pregnancy
- Suspicion in current pregnancy, or occurrence in an earlier pregnancy, of placental abruption
- Drug or alcohol abuse
- Regular intake of fish oil or of non-steroidal antiinflammatory agents or other drugs with an effect on thombocyte function or eicosanoid metabolism
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 |
|---|---|---|
| Low dose fish oilAlso: PikasolFour 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 2.7 g n-3 fatty acids per day. | Dietary supplement | Low dose fish oil |
| Low dose olive oilFour 1 g capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day. | Dietary supplement | Low dose olive oil |
| High dose fish oilAlso: PikasolNine 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 6.1 g n-3 fatty acids per day. | Dietary supplement | High dose fish oil |
| High dose olive oilNine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day. | Dietary supplement | High dose olive oil |
Primary outcome
Pregnancy Induced Hypertension
Time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest
Intrauterine growth retardation
Time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
Birth weight below the 10th centile, as assessed from the infant's birth weight, gestational age and gender, on the basis of Danish standards (Br J Obstet Gynaecol 1986; 93: 128-134; and Acta Obstet Gynecol Scand 1985; 64: 65-70).
Preterm delivery
Time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.
Delivery at an estimated gestational age of less than 259 days (37 completed weeks)
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 1 Sep 2014.
- Results publication: PubMed 10740336Olsen SF, Secher NJ, Tabor A, Weber T, Walker JJ, Gluud C. Randomised clinical trials of fish oil supplementation in high risk pregnancies. Fish Oil Trials In Pregnancy (FOTIP) Team. BJOG. 2000 Mar;107(3):382-95. doi: 10.1111/j.1471-0528.2000.tb13235.x.
- Results publication: PubMed 17299499Olsen SF, Osterdal ML, Salvig JD, Weber T, Tabor A, Secher NJ. Duration of pregnancy in relation to fish oil supplementation and habitual fish intake: a randomised clinical trial with fish oil. Eur J Clin Nutr. 2007 Aug;61(8):976-85. doi: 10.1038/sj.ejcn.1602609. Epub 2007 Feb 7.
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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.
Niels J Secher, Professor principal investigator
Copenhagen University Hospital, Rigshospitalet
Sjurdur F Olsen, Professor principal investigator
Center for Fetal Programming, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Low dose fish oil, Low dose olive oil and High dose fish oil in people with Preterm Birth and Intrauterine Growth Retardation, run by Sjurdur Frodi Olsen.
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 5 inclusion and 6 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 1 Sep 2014. 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?
Pregnancy Induced Hypertension (time frame: Participants will be followed for the duration of pregnancy and the first few days after delivery, on average 20-26 weeks from recruitment and randomization.). The study lists 3 primary outcomes in all. 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 NCT02229526, which also lists 2 linked publications.
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 1 Sep 2014.