NCT02229526: FOTIP

Randomised Clinical Trials of Fish Oil Supplementation in High Risk Pregnancies

Completed NA Last updated 29 August 2014

What this trial tests

NA trial testing Low dose fish oil in Preterm Birth in 1,619 participants. Completed in 1 December 1999.

Timeline

1 January 1990

Primary endpoint
1 January 1996

1 December 1999

Quick facts

Lead sponsor	Sjurdur Frodi Olsen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Enrollment	1,619
Start date	1 January 1990
Primary completion	1 January 1996
Estimated completion	1 December 1999

Drugs / interventions tested

• Low dose fish oil — full drug profile →
• Low dose olive oil
• High dose fish oil — full drug profile →
• High dose olive oil

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →
• Intrauterine Growth Retardation — all drugs for Intrauterine Growth Retardation →
• Pregnancy Induced Hypertension — all drugs for Pregnancy Induced Hypertension →

Sponsor

Sjurdur Frodi Olsen

Who can join

Eligibility, female only, with Preterm Birth or Intrauterine Growth Retardation.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Omega-3 fatty acid addition during pregnancy.
   Middleton P, Gomersall JC, Gould JF, Shepherd E, et al · · 2018 · cited 249× · PMID 30480773 · DOI 10.1002/14651858.cd003402.pub3
2. Effects of vitamin and mineral supplementation during pregnancy on maternal, birth, child health and development outcomes in low- and middle-income countries: A systematic review.
   Keats EC, Oh C, Chau T, Khalifa DS, et al · · 2021 · cited 22× · PMID 37051178 · DOI 10.1002/cl2.1127