Effects of Dietary Nitrate in Hypertensive Pregnant Women

Not Applicable

Completed

• Conditions: Pregnancy; Hypertension
• Interventions: Dietary Supplement: Beetroot juice; Dietary Supplement: Nitrate-depleted beetroot juice

• Registration Number: NCT02520687
• Lead Sponsor: University of Manchester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-08
• Study First Posted: 2015-08-13
• Study Start: 2015-09
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary nitrate, beetroot juice	Beetroot juice	Once daily 70mL dose of beetroot juice, containing 400mg inorganic nitrate, for 7 consecutive days.
Nitrate-depleted beetroot juice	Nitrate-depleted beetroot juice	Once daily 70mL dose of beetroot juice, depleted of nitrate, for 7 consecutive days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Maternal and Fetal Health Research Centre; 🇬🇧 Manchester, United Kingdom