NCT02137408

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 18, 2014

Status Verified

August 1, 2014

Enrollment Period

11 months

First QC Date

May 12, 2014

Last Update Submit

September 17, 2014

Conditions

Hypertension in Pregnancy

Keywords

Chronic hypertension in pregnancyPre-term deliveryPreeclampsiaEndothelial HealthDocosahexaenoic acid (DHA)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Improve immune homeostasis

    Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum

Other Outcomes (1)

  • Decrease the number of infants born <34 weeks

    Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum

Study Arms (2)

200 mg docosahexaenoic acid

ACTIVE COMPARATOR

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

1000 mg docosahexaenoic acid

ACTIVE COMPARATOR

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

Interventions

Docosahexaenoic acid 200 mgDIETARY_SUPPLEMENT

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.

Also known as: 200mg dietary DHA daily (Expecta, Mead Johnson) PO
200 mg docosahexaenoic acid
Docosahexaenoic acid 1000 mgDRUG

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.

Also known as: Dietary DHA (Expecta, Mead Johnson) will be given PO with 5-200mg capsules
1000 mg docosahexaenoic acid

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Bleeding disorders
  • Lupus
  • Autoimmune diseases
  • The presence of infant congenital (trisomy 13,18, 21, urethral, gastrointestinal and cardiac defects)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedPre-Eclampsia

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Christina J Valentine, MD, MS, RD

    Cincinnati Children's Hosptial Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 13, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

April 1, 2016

Last Updated

September 18, 2014

Record last verified: 2014-08

Locations

US(1)