Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Women's Studies, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/8/2014 |
| Start Date: | December 2014 |
| End Date: | April 2016 |
| Contact: | Christina J Valentine, MD, MS, RD |
| Email: | Christina.Valentine@cchmc.org |
| Phone: | 513-636-7584 |
Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health and Reduce the Risks of Preterm Delivery
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.
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.
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.
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.
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)
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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