Effects of Dietary Nitrate in Hypertensive Pregnant Women

NCT ID: NCT02520687

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dietary Nitrate
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dietary nitrate, beetroot juice

Once daily 70mL dose of beetroot juice, containing 400mg inorganic nitrate, for 7 consecutive days.

Group Type EXPERIMENTAL

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

70mls daily for seven days

Nitrate-depleted beetroot juice

Once daily 70mL dose of beetroot juice, depleted of nitrate, for 7 consecutive days.

Group Type PLACEBO_COMPARATOR

Nitrate-depleted beetroot juice

Intervention Type DIETARY_SUPPLEMENT

70mls daily for seven days

Interventions

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Beetroot juice

70mls daily for seven days

Intervention Type DIETARY_SUPPLEMENT

Nitrate-depleted beetroot juice

70mls daily for seven days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Dr Jenny Myers

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maternal and Fetal Health Research Centre

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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15136

Identifier Type: -

Identifier Source: org_study_id

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