Recruiting

DHA

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT04069195

Conditions

Inflammation

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

DHA supplement

Corn Oil: Soybean Oil

Study Details

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 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

Conditions

Inflammation

Pregnancy Related

Study ID

NCT04069195

Start date

Feb 1, 2019

Status verified date

Aug, 2019

Completion date

Dec 1, 2020

Anticipated

Primary completion date

Dec 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: DHA supplement

Patients in the intervention group will recieve a \~1000mg capsule containing \~400mg of DHA. This is not standard of care and is being done for research purposes only. Patients will take this capsule once daily begining between 8-14 weeks of pregnancy until delivery of their infant.

placebo comparator: corn oil: Soybean oil placebo

Patients in the Placebo group will recieve a \~1000mg capusle containing no DHA and filled with 50:50 mix of corn and soybean oils. This oil is ubiquitous in the american diet and only a very small amount of additional oil will be ingested for study purposes. Giving pregnant women this oil is not standard of care and is being done for research purposes only. Patients will continue taking this placebo from enrollment at 8-14 weeks of pregnancy until time of delivery.

Interventions

DHA supplement

Patient's will be randomized to recieve either DHA or 50:50 corn oil/soybean oil supplement as a once daily supplement to be taken from enrollment through delivery of their infant

Corn Oil: Soybean Oil

Patient's will be randomized to recieve either DHA or 50:50 corn oil/soybean oil supplement as a once daily supplement to be taken from enrollment through

Primary outcome measure

  • Measure DHA [ Time Frame: Sample obtained between 8-14 weeks of pregnancy ]
  • Measure DHA [ Time Frame: Sample obtained between 26-30 weeks of pregnancy ]
  • Measure DHA [ Time Frame: Sample obtained from cord blood at time of infant delivery ]
  • Measure synaptamide [ Time Frame: Sample obtained between 8-14 weeks of pregnancy ]
  • Measure synaptamide [ Time Frame: Sample obtained between 26-30 weeks of pregnancy ]
  • Measure synaptamide [ Time Frame: Sample obtained from cord blood at time of infant delivery ]
  • Measure inflammatory biomarkers [ Time Frame: Sample obtained between 8-14 weeks of pregnancy ]
  • Measure inflammatory biomarkers [ Time Frame: Sample obtained between 26-30 weeks of pregnancy ]
  • Measure inflammatory biomarkers [ Time Frame: Sample obtained from cord blood at time of infant delivery ]

Central Contacts and Locations

Central contacts

Peter F Knickerbocker, DO

215-298-2476peteknickerbocker@gmail.com

Carl Hunt, MD

3017675514carl.hunt@usuhs.edu

Locations

Walter Reed National Miltiary medical center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Peter F Knickerbocker, DO

215-298-2476peteknickerbocker@gmail.com

Carl Hunt, MD

3017675514carl.hunt@usuhs.edu

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Aug 28, 2019

Last verified

Aug, 2019

Keywords

  • Inflammation
  • DHA
  • Pregnancy
  • preterm
  • overweight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2019-08-28.