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

Sponsor

Centre for Fetal Programming, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01353807

Collaborator

National Institutes of Health (NIH) (NIH), The Danish Council for Strategic Research (Other), Danish Council for Independent Research (Other), Lundbech Foundation (Other), EU Commision, DG12 (Other)

533

Enrollment

Location

Arms

257.9

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Delivery Atopy Metabolic Syndrome	Dietary Supplement: Fish oil Dietary Supplement: Olive oil	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

533 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Nov 1, 1989

Actual Primary Completion Date :

Dec 1, 1990

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids Other Names: Pikasol
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 4 1-g gelatine capsules with virgin olive oil
No Intervention: No oil supplement These women received no capsules with oil

Arm

Intervention/Treatment

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

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

Other Names:

Pikasol

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

4 1-g gelatine capsules with virgin olive oil

No Intervention: No oil supplement

These women received no capsules with oil

Outcome Measures

Primary Outcome Measures

Gestation length [1989-1990 (1 year)]
We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy pregnant women in gestation week 30

Exclusion Criteria:

Bleeding episodes during pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	DK-8000

Sponsors and Collaborators

Centre for Fetal Programming, Denmark
National Institutes of Health (NIH)
The Danish Council for Strategic Research
Danish Council for Independent Research
Lundbech Foundation
EU Commision, DG12

Investigators

Principal Investigator: Sjurdur F. Olsen, MD, Statens Serum Institut

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01353807

Other Study ID Numbers:

M-AA-20060182
R21AT004603

First Posted:

May 16, 2011

Last Update Posted:

Feb 28, 2014

Last Verified:

Feb 1, 2014

Keywords provided by , ,

Additional relevant MeSH terms:

Premature Birth

Metabolic Syndrome

Study Results

No Results Posted as of Feb 28, 2014