Status:
UNKNOWN
Docosahexaenoic Acid (DHA) Supplementation in High Risk Pregnancies
Lead Sponsor:
Walter Reed National Military Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
DSM Nutritional Products, Inc.
Conditions:
Inflammation
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Purpose: Determine the effects of maternal docosahexaenoic acid (DHA) supplementation during pregnancy on levels of DHA, synaptamide (novel anti-inflammatory metabolite), and inflammatory biomarkers d...
Detailed Description
All pregnant women meeting the inclusion/exclusion criteria will be identified at the time of their regular OB appointments between the 8th and the 14th week of pregnancy (+/- 3 days) Research team me...
Eligibility Criteria
Inclusion
- regnant female military health care beneficiaries ≥18 years of age
- Between the 8th and 14th week of pregnancy at enrollment
- BMI of ≥30.0 kg/m2 and/or history of previous preterm delivery at \<36 weeks gestation
- Planning to deliver at WRNMMC
- DEERS-eligible
- All infants born to mothers enrolled in this study who do not meet any exclusion criteria
Exclusion
- Routine use of DHA supplement (including DHA containing prenatal vitamins) and/or fish consumption greater than twice per week
- Women with a fish allergy
- Known major fetal anomaly believed to be lethal
- Maternal treatment for clotting disorder
- Allergy to corn or soybean oils
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04069195
Start Date
February 1 2019
End Date
December 1 2020
Last Update
August 28 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Walter Reed National Miltiary medical center
Bethesda, Maryland, United States, 20889