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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Danish council for Strategic Research
Danish Council for Independent Research
Lundbech Foundation
EU Commision, DG12
Information provided by:
Centre for Fetal Programming, Denmark
ClinicalTrials.gov Identifier:
NCT01353807
First received: April 29, 2011
Last updated: July 8, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention
Preterm Delivery
Atopy
Metabolic Syndrome
 Dietary Supplement: Fish oil
Dietary Supplement: Olive oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre for Fetal Programming, Denmark:

Primary Outcome Measures:
  • Gestation length [ Time Frame: 1989-1990 (1 year) ] [ Designated as safety issue: Yes ]
    We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery


Enrollment: 533
Study Start Date: November 1989
Study Completion Date: May 2011
Primary Completion Date: December 1990 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy pregnant women in gestation week 30

Exclusion Criteria:

  • Bleeding episodes during pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353807

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
Centre for Fetal Programming, Denmark
National Institutes of Health (NIH)
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
  More Information

Additional Information:
Protocol and correspondences  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Sjurdur Frodi Olsen, Statens Serum Institut, Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT01353807     History of Changes
Other Study ID Numbers: M-AA-20060182, R21AT004603
Study First Received: April 29, 2011
Last Updated: July 8, 2011
Health Authority: Denmark: De Videnskabsetiske Komiteer

Keywords provided by Centre for Fetal Programming, Denmark:
Fish oil
Pregnancy
RCT
Birth weight
 Gestational age
Asthma and allergies
Metabolic syndrome
Obesity

Additional relevant MeSH terms:
Premature Birth
Metabolic Syndrome X
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013