NCT04604535

The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy

The Effects of Dietary Nitrate Supplementation on Pregnancies Complicated by Chronic and New Onset Hypertension

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomised placebo controlled trial investigating the effects of dietary nitrate supplementation on hypertension in pregnancy

Detailed description

Reduced nitrate and nitrite concentrations have been found in women with preeclampsia (PE) and studies have shown increased concentrations of an endogenously generated Nitric Oxide Synthase inhibitor, amongst women with PE. Nitrate and nitrite are required to produce Nitric Oxide (NO). NO is released from the endothelial lining of blood vessels, and acts to relax smooth muscle within the vasculature, acting as a potent vasodilator. Reduced NO concentrations are hence thought to contribute towards the systemic vascular constriction seen in PE. Hypertensive diseases in pregnancy are an important cause of morbidity and mortality in both maternal, fetal and neonatal health. Treatment options are limited in pregnancy and hence alternative methods to improve blood pressure control should be sought. In this randomised placebo controlled double blinded trial we aim to assess the effect of dietary nitrate supplementation on the hypertensive diseases of pregnancy and the subsequent maternal, fetal-neonatal outcomes. The safety and acceptability of dietary nitrate supplementation will also be confirmed in this study.

Conditions

• Hypertension in Pregnancy
• Pre-Eclampsia
• Gestational Hypertension
• Pregnancy Induced Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Concentrated beetroot juice	70mL concentrated beetroot juice (400mg nitrate)
DIETARY_SUPPLEMENT	Placebo	70mL concentrated nitrate deplete beetroot juice (\<0.01mmol/L nitrate)

Timeline

• Start date: 2020-10-22
• Primary completion: 2022-06-30
• Completion: 2022-12-30
• First posted: 2020-10-27
• Last updated: 2020-10-30

Locations

1 site across 1 country: United Kingdom