Docosahexaenoic Acid (DHA) Supplementation in High Risk Pregnancies

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Inflammation, Pregnancy Related

In brief

Purpose: Determine the effects of maternal docosahexaenoic acid (DHA) supplementation during pregnancy on levels of DHA, synaptamide (novel anti-inflammatory metabolite), and inflammatory biomarkers during pregnancy and at delivery Research Design: Double blind randomized placebo-controlled study of maternal DHA supplementation during pregnancy. Methodology /Technical Approach: Investigators plan to enroll 100 pregnant women with a high risk pregnancy related to (1) a pre-pregnancy Body Mass Index (BMI) of ≥30.0 kg/m2 and/or (2) a history of prior preterm delivery at ≤35+6 weeks gestation. Women will be enrolled between the 8th and 14th week of pregnancy and randomized to receive a once daily DHA supplement (DSM Nutritional Products, Columbia Maryland, DHA capsule 441mg/cap) or a placebo (DSM Nutritional Products, Columbia Maryland, Corn Oil/Soybean oil 50/50 mix) for the duration of the pregnancy. DHA is an omega-3 long chain polyunsaturated fatty acid (LCPUFA) and placebo composed of omega-6 LCPUFA's. Investigators will measure maternal levels of plasma DHA, Synaptamide and inflammatory biomarkers at enrollment, at 26-30 weeks of pregnancy, and from cord blood at delivery. Sociodemographic and clinical characteristics will be collected for each mother from pregnancy onset until discharge following delivery. The infant health record and parental report will be reviewed to record clinical data from birth to 12 months corrected age for short term health outcomes potentially related to inflammation-related morbidities, including growth and development, acute infection requiring hospital admission, and any allergic disorder. All plasma samples will be processed at Dr. Kim's NIAAA/NIH laboratories using high-performance liquid chromatography with tandem mass spectrometry

Key facts

Study ID

NCT04069195

Run by

Walter Reed National Military Medical Center

People needed

210

Starts

2019-02-01

Expected to finish

2020-12-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Walter Reed National Miltiary medical center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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