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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353807
• Other study ID #: M-AA-20060182
• Secondary ID: R21AT004603
• Status: Completed
• Phase: N/A
• First received: April 29, 2011
• Last updated: February 27, 2014
• Start date: November 1989
• Est. completion date: May 2011

Study information

• Verified date: February 2014
• Source: Centre for Fetal Programming, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: De Videnskabsetiske Komiteer
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 533
• Est. completion date: May 2011
• Est. primary completion date: December 1990
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy pregnant women in gestation week 30

Exclusion Criteria:

• Bleeding episodes during pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atopy
• Metabolic Syndrome
• Metabolic Syndrome X
• Premature Birth
• Preterm Delivery

Intervention

Dietary Supplement:
• Fish oil
4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids
• Olive oil
4 1-g gelatine capsules with virgin olive oil

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (6)

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

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

Olsen SF, Østerdal 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 — View Citation

Olsen SF, Sørensen 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. — View 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. — View 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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestation length	We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery	1989-1990 (1 year)	Yes

External Links

•   Protocol and correspondences