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

Primary Purpose

Preterm Delivery, Atopy, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fish oil
Olive oil
Sponsored by
Centre for Fetal Programming, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Preterm Delivery focused on measuring Fish oil, Pregnancy, RCT, Birth weight, Gestational age, Asthma and allergies, Metabolic syndrome, Obesity

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy pregnant women in gestation week 30

Exclusion Criteria:

  • Bleeding episodes during pregnancy

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Fish oil supplementation

Olive oil

No oil supplement

Arm Description

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

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

These women received no capsules with oil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 29, 2011
Last Updated
February 27, 2014
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
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1. Study Identification

Unique Protocol Identification Number
NCT01353807
Brief Title
Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health
Official Title
Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 1989 (undefined)
Primary Completion Date
December 1990 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery, Atopy, Metabolic Syndrome
Keywords
Fish oil, Pregnancy, RCT, Birth weight, Gestational age, Asthma and allergies, Metabolic syndrome, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
533 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil supplementation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Olive oil
Arm Type
Placebo Comparator
Arm Description
These women received 4 1-g capsules with olive oil per day from gestational week 30 until delivery
Arm Title
No oil supplement
Arm Type
No Intervention
Arm Description
These women received no capsules with oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Other Intervention Name(s)
Pikasol
Intervention Description
4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil
Intervention Description
4 1-g gelatine capsules with virgin olive oil
Primary Outcome Measure Information:
Title
Gestation length
Description
We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery
Time Frame
1989-1990 (1 year)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy pregnant women in gestation week 30 Exclusion Criteria: Bleeding episodes during pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sjurdur F. Olsen, MD
Organizational Affiliation
Statens Serum Institut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
1349049
Citation
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.
Results Reference
result
PubMed Identifier
18614738
Citation
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.
Results Reference
result
PubMed Identifier
21775563
Citation
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.
Results Reference
result
PubMed Identifier
21874272
Citation
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.
Results Reference
result
PubMed Identifier
22313729
Citation
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.
Results Reference
result
Links:
URL
http://cfp-research.com/Research/Publications/Sjurdur%20F%20Olsen.aspx
Description
Protocol and correspondences

Learn more about this trial

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

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