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

Primary Purpose

Hypertension in Pregnancy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Docosahexaenoic acid 200 mg
Docosahexaenoic acid 1000 mg
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension in Pregnancy focused on measuring Chronic hypertension in pregnancy, Pre-term delivery, Preeclampsia, Endothelial Health, Docosahexaenoic acid (DHA)

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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)

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

200 mg docosahexaenoic acid

1000 mg docosahexaenoic acid

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 12, 2014
Last Updated
September 17, 2014
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02137408
Brief Title
Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health
Acronym
DHA-2
Official Title
Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health and Reduce the Risks of Preterm Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Why Stopped
PI no longer at Institution
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy
Keywords
Chronic hypertension in pregnancy, Pre-term delivery, Preeclampsia, Endothelial Health, Docosahexaenoic acid (DHA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
200 mg docosahexaenoic acid
Arm Type
Active Comparator
Arm 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.
Arm Title
1000 mg docosahexaenoic acid
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Docosahexaenoic acid 200 mg
Other Intervention Name(s)
200mg dietary DHA daily (Expecta, Mead Johnson) PO
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docosahexaenoic acid 1000 mg
Other Intervention Name(s)
Dietary DHA (Expecta, Mead Johnson) will be given PO with 5-200mg capsules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improve maternal endothelial health
Description
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.
Time Frame
Pregnant mothers 18-20 weeks gestation (Baseline) - Six weeks post partum
Secondary Outcome Measure Information:
Title
Improve immune homeostasis
Description
Measured by decreased maternal blood and cord blood concentrations of pro-inflammatory cytokines IL-6, I L-8, TNF a, and receptor sRAGE.
Time Frame
Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum
Other Pre-specified Outcome Measures:
Title
Decrease the number of infants born <34 weeks
Description
In addition to the primary aims, we will examine evidence that DHA will prolong gestation
Time Frame
Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina J Valentine, MD, MS, RD
Organizational Affiliation
Cincinnati Children's Hosptial Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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