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NCT02520687 Clinical Trial

Effects of Dietary Nitrate in Hypertensive Pregnant Women

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02520687
Other study ID # 15136
Secondary ID
Status Completed
Phase Phase 1
First received August 5, 2015
Last updated July 18, 2017
Start date September 2015
Est. completion date February 2017

Study information
Verified date July 2017
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Female
Age group 16 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Beetroot juice
200mls daily for seven days
• Nitrate-depleted beetroot juice
200mls daily for seven days

Locations
Country Name City State
United Kingdom Maternal and Fetal Health Research Centre Manchester

Sponsors (1)
Lead Sponsor Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

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