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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02229526
Other study ID # DT2006-41-6257
Secondary ID
Status Completed
Phase N/A
First received March 3, 2014
Last updated August 29, 2014
Start date January 1990
Est. completion date December 1999

Study information

Verified date August 2014
Source Centre for Fetal Programming, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The National Committee on Health Research Ethics
Study type Interventional

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


Recruitment information / eligibility

Status Completed
Enrollment 1619
Est. completion date December 1999
Est. primary completion date January 1996
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)


Intervention

Dietary Supplement:
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Sjurdur Frodi Olsen Rigshospitalet, Denmark

References & Publications (2)

Olsen SF, Østerdal 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. Epub 2007 Feb 7. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
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