NCT02229526

Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')

Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,619 (actual)
• Sponsor: Sjurdur Frodi Olsen · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: —

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.

Conditions

• Preterm Birth
• Intrauterine Growth Retardation
• Pregnancy Induced Hypertension

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 1990-01-01
• Primary completion: 1996-01-01
• Completion: 1999-12-01
• First posted: 2014-09-01
• Last updated: 2014-09-01