NCT01353807

Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health

Completed NA Last updated 27 February 2014

What this trial tests

NA trial testing Fish oil in Preterm Delivery in 533 participants. Completed in 1 May 2011.

Timeline

1 November 1989

Primary endpoint
1 December 1990

1 May 2011

Quick facts

Lead sponsor	Centre for Fetal Programming, Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	533
Start date	1 November 1989
Primary completion	1 December 1990
Estimated completion	1 May 2011
Sites	1 location across Denmark

Drugs / interventions tested

• Fish oil — full drug profile →
• Olive oil — full drug profile →

Conditions studied

• Preterm Delivery — all drugs for Preterm Delivery →
• Atopy — all drugs for Atopy →
• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Centre for Fetal Programming, Denmark

Who can join

Adults 20 to 50, female only, with Preterm Delivery or Atopy. Healthy volunteers can join.

What's being measured

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

• Gestation length
  Time frame: 1989-1990 (1 year)
  We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery

Sponsor's own description

The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant women, while they were in gestational week 30, were randomized to fish oil supplements providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no supplements; they were asked to take the supplements until delivery. Health outcomes were assessed during pregnancy and delivery. Further, offspring health and development has been examined during the ensuring two decades by making linkages to the rich Danish health and administrative registries, by asking the offspring to complete web-based questionnaires, and by examining the offspring physically.

Publications & conference data

4 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. Maternal prenatal and/or postnatal n-3 long chain polyunsaturated fatty acids (LCPUFA) supplementation for preventing allergies in early childhood.
   Gunaratne AW, Makrides M, Collins CT. · · 2015 · cited 64× · PMID 26197477 · DOI 10.1002/14651858.cd010085.pub2
3. Lack of iron, zinc, and vitamins as a contributor to the etiology of atopic diseases.
   Peroni DG, Hufnagl K, Comberiati P, Roth-Walter F. · · 2022 · cited 56× · PMID 36698466 · DOI 10.3389/fnut.2022.1032481
4. 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