Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health (DHA-2)

Cincinnati Children's Hospital Medical Center

Status: Withdrawn

Conditions: Hypertension in Pregnancy

Treatments: Dietary Supplement: Docosahexaenoic acid 200 mg; Drug: Docosahexaenoic acid 1000 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02137408

2013-7329

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

200 mg docosahexaenoic acid

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Docosahexaenoic acid 200 mg

1000 mg docosahexaenoic acid

Active Comparator group

Description:

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.

Treatment:

Drug: Docosahexaenoic acid 1000 mg