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

Last updated: October 29, 2020
Sponsor: King's College Hospital NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

High Blood Pressure (Hypertension - Pediatric)

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT04604535
263871
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥18
  • Able to give written informed consent
  • Singleton pregnancies, between 24+0 to 36+6 weeks gestation with new onset gestationalhypertension (defined by ISSHP2018 as new onset BP >140/90 and no evidence ofproteinuria, biochemical or haematological abnormalities or fetal growth restriction)Or
  • Singleton pregnancies, between 24+0 - 36+6 weeks gestation, with chronic hypertension (defined by ISSHP2018 as BP ≥140/90 predating the pregnancy or recognised at <20week's gestation) Or
  • Singleton pregnancies, between 24+0 - 36+6 weeks gestation, with preeclampsia (definedby ISSHP2018 as Gestational hypertension accompanied by ≥ 1 of the following new onsetconditions at or after 20 weeks' gestation:
  • Proteinuria (24h urine collection>300mg/day, Protein-creatinine ratio>30 mg/mmol)
  • Other markers of maternal organ dysfunction, including:
  • Acute Kidney Injury (AKI) (creatinine ≥90μmol/L; 1mg/dL)
  • Liver involvement (elevated transaminases e.g. alanine transaminase (ALT) or aspartateaminotransferase (AST) >40IU/L) with or without right upper quadrant or epigastricabdominal pain
  • Neurological complications e.g. eclampsia, altered mental status, blindness, stroke,clonus, severe headaches and persistent visual scotomata
  • Haematological complications (thrombocytopenia - platelet count <150 000/μL,disseminated intravascular coagulation, haemolysis
  • Uteroplacental dysfunction (fetal growth restriction, abnormal umbilical arterydoppler wave form analysis, or stillbirth)

Exclusion

Exclusion Criteria:

  • Unable to tolerate taste of beetroot juice concentrate during taste test
  • Multiple pregnancy
  • History of acute or chronic liver conditions (aside from preeclampsia)
  • Fetal aneuploidies or major fetal anomalies
  • Unwillingness to comply with all study-related procedures e.g. Women who have usedmouthwash or tongue scraping in last 7 days and are not able/unwilling unable to stopthis for the duration of the study
  • Women on treatment for gingivitis
  • Women with persistent hyperemesis or ptyalism
  • On Proton-pump-inhibitors/antacids other treatment for gastritis/peptic ulcer/gastriculcers
  • Those with long term antibiotic use e.g. prophylaxis of urinary tract infections (UTIs) or those who are likely to need repeated courses of antibiotics e.g. history ofrecurrent UTI
  • Women with known allergy/intolerance to beetroot or lemon
  • Type 1 and Type 2 diabetics
  • Moderate iron deficiency anaemia with haemoglobin <100g/dL and/or ferritin <15μg/L
  • Any blood disorder or significant illness that may affect platelet function andcoagulation. However, patients taking low-dose aspirin (150mg) for preeclampsiaprophylaxis who are at increased risk of developing preeclampsia will be included inthe study.
  • History of alcohol or recreational drug abuse use within the past 6 months
  • Systemic autoimmune disease e.g. Rheumatoid Arthritis, antiphospholipid syndromeconnective tissue disease e.g. Systemic Lupus Erythematous or other conditions knownto be associated with chronic inflammation such as inflammatory bowel disease -Chron's disease/Ulcerative Colitis
  • Women not intending to deliver at the recruiting site
  • Participating in another intervention study that influences the outcomes of this study
  • Those with serious mental illness or learning difficulties and unable to give writteninformed consent
  • Those who are detained as a prisoner or detained in any secured unit, including thoseheld under the Mental Health Act
  • Those not fluent in local language, and absence of appropriate interpreter despite useof services such as Language Line

Study Design

Total Participants: 320
Study Start date:
October 22, 2020
Estimated Completion Date:
December 30, 2022

Study 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.

Connect with a study center

  • King's College Hospital

    London,
    United Kingdom

    Active - Recruiting

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