Metabolic Syndrome Clinical Trial
Official title:
Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
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 |
Denmark,
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
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 |
Status | Clinical Trial | Phase | |
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