Effects of Dietary Nitrate in Hypertensive Pregnant Women

July 18, 2017 updated by: Dr Jenny Myers, University of Manchester

Feasibility Study on the Effects of Dietary Nitrate on Cardiovascular Function in Hypertensive Pregnant Women

High blood pressure in pregnancy affects around 10% of pregnancies, and is associated with serious adverse outcomes for both mother and baby. Treatment options for the management of high blood pressure in pregnancy are currently limited. Studies in non-pregnant individuals have shown that supplementation with dietary nitrate, using beetroot juice, can significantly lower blood pressure and improve blood flow. This study aims to investigate whether supplementation with dietary nitrate (via beetroot juice) can improve blood pressure regulation in pregnant women with chronic high blood pressure, and will also determine whether this can improve blood flow across the placenta.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Maternal and Fetal Health Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women diagnosed with chronic hypertension (systolic blood pressure of 130-144 mmHg and/or diastolic blood pressure of 80-94 mmHg).
  • Between 22 - 35+6 weeks gestation

Exclusion Criteria:

  • Multi-fetal pregnancy
  • Currently taking anti-hypertensive medication
  • Pre-existing diabetes (Type 1 or Type 2)
  • Lacking ability to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary nitrate, beetroot juice
Once daily 70mL dose of beetroot juice, containing 400mg inorganic nitrate, for 7 consecutive days.
Dietary supplement: Beetroot juice
200mls daily for seven days
Placebo Comparator: Nitrate-depleted beetroot juice
Once daily 70mL dose of beetroot juice, depleted of nitrate, for 7 consecutive days.
Dietary supplement: Nitrate-depleted beetroot juice
200mls daily for seven days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in clinic blood pressure (compared to baseline) between treatment and placebo groups
Time Frame: The outcome will be determined after 7 days treatment (compared to baseline)
The outcome will be determined after 7 days treatment (compared to baseline)

Secondary Outcome Measures

Outcome Measure
Time Frame
Recruitment rates
Time Frame: Across study (18 months)
Across study (18 months)
Uterine artery blood flow (compared to baseline)
Time Frame: The outcome will be determined after 7 days treatment (compared to baseline)
The outcome will be determined after 7 days treatment (compared to baseline)
Umbilical artery blood flow (compared to baseline)
Time Frame: The outcome will be determined after 7 days treatment (compared to baseline)
The outcome will be determined after 7 days treatment (compared to baseline)
Changes in plasma and salivary nitrate concentrations
Time Frame: The outcome will be determined after 7 days treatment (compared to baseline)
The outcome will be determined after 7 days treatment (compared to baseline)
Changes in plasma and salivary nitrite concentrations
Time Frame: The outcome will be determined after 7 days treatment (compared to baseline)
The outcome will be determined after 7 days treatment (compared to baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 8, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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