Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')
NCT ID: NCT02229526
Last Updated: 2014-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1619 participants
INTERVENTIONAL
1990-01-31
1999-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Low dose fish oil
Low dose fish oil
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 oil
Low dose olive oil
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 oil
High dose fish oil
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 oil
High dose olive oil
Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
Interventions
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Low dose fish oil
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 oil
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 oil
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 oil
Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
FEMALE
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Sjurdur Frodi Olsen
OTHER
Responsible Party
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Sjurdur Frodi Olsen
Chief Physician, Centre-Leader
Principal Investigators
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Niels J Secher, Professor
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Sjurdur F Olsen, Professor
Role: PRINCIPAL_INVESTIGATOR
Center for Fetal Programming, Denmark
References
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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.
Olsen 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.
Other Identifiers
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DT2006-41-6257
Identifier Type: -
Identifier Source: org_study_id
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