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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension in Pregnancy
• Intervention / Treatment: Dietary supplement: Docosahexaenoic acid 200 mg; Drug: Docosahexaenoic acid 1000 mg

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 200 mg docosahexaenoic acid; 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; 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.; Other Names: 200mg dietary DHA daily (Expecta, Mead Johnson) PO
Active Comparator: 1000 mg docosahexaenoic acid; 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; 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.; Other Names: Dietary DHA (Expecta, Mead Johnson) will be given PO with 5-200mg capsules

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Nationwide Children's Hospital
• Investigators: Principal Investigator: Christina J Valentine, MD, MS, RD, Cincinnati Children's Hosptial Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Docosahexaenoic acid (DHA); Preeclampsia; Chronic hypertension in pregnancy; Pre-term delivery; Endothelial Health
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 2013-7329