Clinical trial NCT02137408: Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health
Official title: Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health and Reduce the Risks of Preterm Delivery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension in Pregnancy
Keywords: Chronic hypertension in pregnancy
Pre-term delivery
Preeclampsia
Endothelial Health
Docosahexaenoic acid (DHA)
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2014-05-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women coming for their 19-20 week ultrasound for fetal anatomy and that have been diagnosed with hypertension by their Obstetrician will be eligible for inclusion.

Exclusion Criteria:

* Exclusions to enrollment will include: women \< 18 years old
* Bleeding disorders
* Lupus
* Autoimmune diseases
* The presence of infant congenital (trisomy 13,18, 21, urethral, gastrointestinal and cardiac defects)

Primary outcomes:
measure: Improve maternal endothelial health
timeFrame: Pregnant mothers 18-20 weeks gestation (Baseline) - Six weeks post partum
Secondary outcomes:
measure: Improve immune homeostasis
timeFrame: Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum
Other outcomes:
measure: Decrease the number of infants born <34 weeks
timeFrame: Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's Hosptial Medical Center
name: Christina J Valentine, MD, MS, RD
role: PRINCIPAL_INVESTIGATOR
References: