Effects of Dietary Nitrate in Hypertensive Pregnant Women

NCT02520687 | Completed

• 1 other identifier: 15136
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in clinic blood pressure (compared to baseline) between treatment and placebo groups

  The outcome will be determined after 7 days treatment (compared to baseline)

Secondary Outcomes (5)

• Recruitment rates

  Across study (18 months)

• Uterine artery blood flow (compared to baseline)

  The outcome will be determined after 7 days treatment (compared to baseline)

• Umbilical artery blood flow (compared to baseline)

  The outcome will be determined after 7 days treatment (compared to baseline)

• Changes in plasma and salivary nitrate concentrations

  The outcome will be determined after 7 days treatment (compared to baseline)

• Changes in plasma and salivary nitrite concentrations

  The outcome will be determined after 7 days treatment (compared to baseline)

Study Arms (2)

Dietary nitrate, beetroot juice

EXPERIMENTAL

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

Dietary Supplement: Beetroot juice

Nitrate-depleted beetroot juice

PLACEBO COMPARATOR

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

Dietary Supplement: Nitrate-depleted beetroot juice

Interventions

Beetroot juice DIETARY_SUPPLEMENT

70mls daily for seven days

Dietary nitrate, beetroot juice

Nitrate-depleted beetroot juice DIETARY_SUPPLEMENT

70mls daily for seven days

Nitrate-depleted beetroot juice

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Maternal and Fetal Health Research Centre

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Dietary Nitrate

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 13, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

GB (1)