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

Hypertension in Pregnancy Clinical Trial

— DHA-2  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02137408
• Other study ID #: 2013-7329
• Status: Withdrawn
• Phase: N/A
• First received: May 12, 2014
• Last updated: September 17, 2014
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2014
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia

Intervention

Dietary Supplement:
• Docosahexaenoic acid 200 mg
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.

Drug:
• Docosahexaenoic acid 1000 mg
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decrease the number of infants born <34 weeks	In addition to the primary aims, we will examine evidence that DHA will prolong gestation	Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum	No
Primary	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	No
Secondary	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	No