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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension in Pregnancy

Intervention / Treatment
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* Dietary Supplement: Docosahexaenoic acid 200 mg
* Drug: Docosahexaenoic acid 1000 mg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 200 mg docosahexaenoic acid<br>Participants will be randomized to 200 mg of docosahexaenoic acid (DHA) administered PO daily (1-200mg capsule of DHA). This is a standard dose used in prenatal vitamins. Participants will be supplemented by mouth daily between 18-20 weeks gestation through 6 weeks post-partum. | Dietary Supplement: Docosahexaenoic acid 200 mg<br>* Participants will be randomized to 200 mg docosahexaenoic acid daily (1-200mg capsule) PO beginning at 18-20 weeks gestation through 6 weeks post-partum.<br>* Other names: 200mg dietary DHA daily (Expecta, Mead Johnson) PO;|
| Active Comparator: 1000 mg docosahexaenoic acid<br>Participants will be randomized to 1000 mg of docosahexaenoic acid (DHA) administered PO daily (5- 200mg capsules of DHA). Participants will be supplemented daily PO between 18-20 weeks gestation through 6 weeks post-partum. | Drug: Docosahexaenoic acid 1000 mg<br>* Participants will be randomized to 1000 mg (5-200mg capsules) docosahexaenoic acid PO daily beginning at 18-20 weeks gestation through 6 weeks post-partum.<br>* Other names: Dietary DHA (Expecta, Mead Johnson) will be given PO with 5-200mg capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve maternal endothelial health | 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. | Pregnant mothers 18-20 weeks gestation (Baseline) - Six weeks post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve immune homeostasis | Measured by decreased maternal blood and cord blood concentrations of pro-inflammatory cytokines IL-6, I L-8, TNF a, and receptor sRAGE. | Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hypertension in pregnancy, Pre-term delivery, Preeclampsia, Endothelial Health, Docosahexaenoic acid (DHA)