Clinical Trial: Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health and Reduce the Risks of Preterm Delivery

Brief Summary: The Investigator would like to see if taking a DHA supplement at a dose recommended for heart health will improve brachial artery dilation (relaxation) and help blood pressure. As a second goal the Investigator would like to see if this supplement can delay preterm delivery by improving heart health. In this research study, the Investigator is asking pregnant women with chronic high blood pressure to take Expecta (DHA - Martek Biosciences, now known as DSM Nutritional Lipil) during the last half of their pregnancy until six weeks after they deliver their baby.

Detailed Summary: The Investigator will be supplementing pregnant mothers with Expecta. This is an over the counter supplement often used by pregnant and nursing mothers and will be given to expectant mothers during the research study. This DHA supplement is available to anyone at most any store. The dose often used over the counter is 200mg, we are testing the heart recommended dose of 1000mg. Because the Investigator is using the heart health recommended dose and because there may be a health claim, the Investigator is doing the study using an FDA- food and drug administration IND. IND means investigational drug. This dose has recently been used safely and effectively in pregnancy both here in the United States and in Australia in hundreds of women. There are no risks to the fetus as the placenta prefers to transfer this important nutrient for fetal eye and brain development. The large studies done in pregnancy have followed their babies into school age and found no adverse effects.
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome: Improve maternal endothelial health [ Time Frame: Pregnant mothers 18-20 weeks gestation (Baseline) - Six weeks post partum ]

To test this hypothesis, the Investigator will undertake a RCT of 90 women with hypertension (chronic or newly diagnosed) in the second trimester of pregnancy, who will be randomized to 1000mg DHA or standard supplement and followed through to delivery with serial measures of blood pressure and vascular constriction by the Doppler method.


Original Primary Outcome: Improve maternal endothelial health [ Time Frame: Pregnant mothers 18-20 weeks gestation (Baseline) - Six weeks post partum ]

To test this hypothesis we will undertake a RCT of 90 women with hypertension (chronic or newly diagnosed) in the second trimester of pregnancy, who will be randomized to 1000mg DHA or standard supplement and followed through to delivery with serial measures of blood pressure and vascular constriction by the Doppler method.


Current Secondary Outcome: Improve immune homeostasis [ Time Frame: Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum ]

Measured by decreased maternal blood and cord blood concentrations of pro-inflammatory cytokines IL-6, I L-8, TNF a, and receptor sRAGE.


Original Secondary Outcome: Same as current

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: May 12, 2014
Date Started: December 2014
Date Completion: April 2016
Last Updated: September 17, 2014
Last Verified: August 2014