CClinicalTrials.gg
CompletedNCT01353807Updated Feb 28, 2014

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

An interventional study of Fish oil and Olive oil in Preterm Delivery, Atopy and Metabolic Syndrome, sponsored by Centre for Fetal Programming, Denmark. Completed at 1 site in Denmark. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-28.

Sponsored by Centre for Fetal Programming, Denmark · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
533
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Female
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Study summary

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.

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Conditions studied

  • Preterm Delivery
  • Atopy
  • Metabolic Syndrome

Keywords

  • Fish oil
  • Pregnancy
  • RCT
  • Birth weight
  • Gestational age
  • Asthma and allergies
  • Metabolic syndrome
  • Obesity
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In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 533 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Centre for Fetal Programming, Denmark is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy pregnant women in gestation week 30

Exclusion criteria

Exclusion Criteria:

  • Bleeding episodes during pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
533 participants (actual)

Study arms

  • Active comparator
    Fish oil supplementation

    These women received 4 1-g capsules of fish oil per day providing 2,7 grams long chain n-3 fatty acids per day, from gestation week 30 until delivery

    Dietary Supplement: Fish oil

  • Placebo comparator
    Olive oil

    These women received 4 1-g capsules with olive oil per day from gestational week 30 until delivery

    Dietary Supplement: Olive oil

  • No intervention
    No oil supplement

    These women received no capsules with oil

Interventions

  • Dietary supplementFish oil

    4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids

    Also known as: Pikasol

  • Dietary supplementOlive oil

    4 1-g gelatine capsules with virgin olive oil

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What researchers measure

Primary outcomes

  1. Gestation length

    We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery

    Time frame: 1989-1990 (1 year)

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, DK-8000, Denmark
08

References and documents

Publications

  • Olsen SF, Sorensen JD, Secher NJ, Hedegaard M, Henriksen TB, Hansen HS, Grant A. Randomised controlled trial of effect of fish-oil supplementation on pregnancy duration. Lancet. 1992 Apr 25;339(8800):1003-7. doi: 10.1016/0140-6736(92)90533-9. PubMed 1349049 ↗
  • Olsen SF, Osterdal ML, Salvig JD, Mortensen LM, Rytter D, Secher NJ, Henriksen TB. Fish oil intake compared with olive oil intake in late pregnancy and asthma in the offspring: 16 y of registry-based follow-up from a randomized controlled trial. Am J Clin Nutr. 2008 Jul;88(1):167-75. doi: 10.1093/ajcn/88.1.167. PubMed 18614738 ↗
  • Rytter D, Bech BH, Christensen JH, Schmidt EB, Henriksen TB, Olsen SF. Intake of fish oil during pregnancy and adiposity in 19-y-old offspring: follow-up on a randomized controlled trial. Am J Clin Nutr. 2011 Sep;94(3):701-8. doi: 10.3945/ajcn.111.014969. Epub 2011 Jul 20. PubMed 21775563 ↗
  • Rytter D, Schmidt EB, Bech BH, Christensen JH, Henriksen TB, Olsen SF. Fish oil supplementation during late pregnancy does not influence plasma lipids or lipoprotein levels in young adult offspring. Lipids. 2011 Dec;46(12):1091-9. doi: 10.1007/s11745-011-3606-5. Epub 2011 Aug 27. PubMed 21874272 ↗
  • Rytter D, Christensen JH, Bech BH, Schmidt EB, Henriksen TB, Olsen SF. The effect of maternal fish oil supplementation during the last trimester of pregnancy on blood pressure, heart rate and heart rate variability in the 19-year-old offspring. Br J Nutr. 2012 Oct 28;108(8):1475-83. doi: 10.1017/S0007114511006799. Epub 2012 Feb 7. PubMed 22313729 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01353807
Lead sponsor
Centre for Fetal Programming, Denmark
Collaborators
National Institutes of Health (NIH), The Danish Council for Strategic Research, Danish Council for Independent Research, Lundbech Foundation, EU Commision, DG12
First posted
May 16, 2011
Start date
Nov 1989
Primary completion
Dec 1990
Completion
May 2011
Last update
Feb 28, 2014

Study contacts

Sjurdur F. Olsen, MD
principal investigator · Statens Serum Institut

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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