NCT02229526

Brief 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. The study was designed as a multi-centre clinical trial based in 19 hospitals in seven countries in Europe.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,619

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1990

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1990

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1996

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1999

Completed
14.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

6 years

First QC Date

March 3, 2014

Last Update Submit

August 29, 2014

Conditions

Preterm BirthIntrauterine Growth RetardationPregnancy Induced Hypertension

Keywords

Fish oil supplementationRCTHigh risk pregnanciesTwin pregnancyPreterm birthIntrauterine growth retardationPregnancy induced hypertension

Outcome Measures

Primary Outcomes (3)

  • Pregnancy Induced Hypertension

    One or more recorded measurements of a diastolic blood pressure of above 90 mmHg at rest

    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).

    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)

    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.

Study Arms (4)

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

Interventions

Low dose fish oilDIETARY_SUPPLEMENT

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.

Also known as: Pikasol
Low dose fish oil
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.

Low dose olive oil
High dose fish oilDIETARY_SUPPLEMENT

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.

Also known as: Pikasol
High dose fish oil
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.

High dose olive oil

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 10740336RESULT

  • 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.

    PMID: 17299499RESULT

MeSH Terms

Conditions

Premature BirthFetal Growth RetardationHypertension, Pregnancy-Induced

Interventions

Fish OilsPikasolOlive Oil

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsDietary Fats, UnsaturatedDietary FatsFatsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Niels J Secher, Professor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Sjurdur F Olsen, Professor

    Center for Fetal Programming, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician, Centre-Leader

Study Record Dates

First Submitted

March 3, 2014

First Posted

September 1, 2014

Study Start

January 1, 1990

Primary Completion

January 1, 1996

Study Completion

December 1, 1999

Last Updated

September 1, 2014

Record last verified: 2014-08