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

NCT ID: NCT01353807

Last Updated: 2014-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

533 participants

Study Classification

INTERVENTIONAL

Study Start Date

1989-11-30

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Delivery Atopy Metabolic Syndrome

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Fish oil

Intervention Type DIETARY_SUPPLEMENT

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

Olive oil

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

Group Type PLACEBO_COMPARATOR

Olive oil

Intervention Type DIETARY_SUPPLEMENT

4 1-g gelatine capsules with virgin olive oil

No oil supplement

These women received no capsules with oil

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fish oil

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

Intervention Type DIETARY_SUPPLEMENT

Olive oil

4 1-g gelatine capsules with virgin olive oil

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Pikasol

Eligibility Criteria

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Inclusion Criteria

* Healthy pregnant women in gestation week 30

Exclusion Criteria

* Bleeding episodes during pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

The Danish Council for Strategic Research

OTHER

Sponsor Role collaborator

Danish Council for Independent Research

OTHER

Sponsor Role collaborator

Lundbech Foundation

UNKNOWN

Sponsor Role collaborator

EU Commision, DG12

UNKNOWN

Sponsor Role collaborator

Centre for Fetal Programming, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Statens Serum Institut, Copenhagen, Denmark

Principal Investigators

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Sjurdur F. Olsen, MD

Role: PRINCIPAL_INVESTIGATOR

Statens Serum Institut

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 1349049 (View on PubMed)

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.

Reference Type RESULT
PMID: 18614738 (View on PubMed)

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.

Reference Type RESULT
PMID: 21775563 (View on PubMed)

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.

Reference Type RESULT
PMID: 21874272 (View on PubMed)

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.

Reference Type RESULT
PMID: 22313729 (View on PubMed)

Related Links

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http://cfp-research.com/Research/Publications/Sjurdur%20F%20Olsen.aspx

Protocol and correspondences

Other Identifiers

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R21AT004603

Identifier Type: NIH

Identifier Source: secondary_id

View Link

M-AA-20060182

Identifier Type: -

Identifier Source: org_study_id