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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


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
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