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

NCT04604535 | Unknown

• 1 other identifier: 263871
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Gestational age of delivery secondary to preeclampsia

  From recruitment until delivery

Secondary Outcomes (8)

• Gestational age of delivery (due to any cause)

  From recruitment until delivery

• Will beetroot juice supplementation increase or decrease the likelihood of maternal complications, including severe maternal complications

  From recruitment until 8 weeks postnatal

• Will beetroot juice supplementation increase or decrease the likelihood of severe hypertension

  From recruitment until 8 weeks postnatal

• Will beetroot juice supplementation result in significant changes in systolic blood pressure and diastolic blood pressure

  From recruitment until 8 weeks postnatal

• Will beetroot juice supplementation result in a significant change in the maximal number and dosages of antihypertensive medications required for blood pressure control

  From recruitment until 8 weeks postnatal

Study Arms (2)

Concentrated beetroot juice

ACTIVE COMPARATOR

70mL of concentrated beetroot juice with 400mg nitrate

Dietary Supplement: Concentrated beetroot juice

Placebo

PLACEBO COMPARATOR

70mL of concentrated beetroot juice with \<0.01mmol/L nitrate

Dietary Supplement: Placebo

Interventions

Concentrated beetroot juice DIETARY_SUPPLEMENT

70mL concentrated beetroot juice (400mg nitrate)

Concentrated beetroot juice

Placebo DIETARY_SUPPLEMENT

70mL concentrated nitrate deplete beetroot juice (\<0.01mmol/L nitrate)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18
• Able to give written informed consent
• Singleton pregnancies, between 24+0 to 36+6 weeks gestation with new onset gestational hypertension (defined by ISSHP2018 as new onset BP \>140/90 and no evidence of proteinuria, 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 \<20 week's gestation) Or
• Singleton pregnancies, between 24+0 - 36+6 weeks gestation, with preeclampsia (defined by ISSHP2018 as Gestational hypertension accompanied by ≥ 1 of the following new onset conditions 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 aspartate aminotransferase (AST) \>40IU/L) with or without right upper quadrant or epigastric abdominal 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 artery doppler wave form analysis, or stillbirth)

You may not qualify if:

• 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 used mouthwash or tongue scraping in last 7 days and are not able/unwilling unable to stop this 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/gastric ulcers
• 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 of recurrent 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 and coagulation. However, patients taking low-dose aspirin (150mg) for preeclampsia prophylaxis who are at increased risk of developing preeclampsia will be included in the study.
• History of alcohol or recreational drug abuse use within the past 6 months
• Systemic autoimmune disease e.g. Rheumatoid Arthritis, antiphospholipid syndrome connective tissue disease e.g. Systemic Lupus Erythematous or other conditions known to be associated with chronic inflammation such as inflammatory bowel disease - Chron's disease/Ulcerative Colitis

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Fetal Medicine Foundation: collaborator
• Barts and the London School of Medicine and Dentistry: collaborator

Study Sites (1)

King's College Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nick Kametas

  Fetal Medicine Research Institute, King's College Hospital London

  STUDY CHAIR

• Kypros Nicolaides

  Fetal Medicine Research Institute, King's College Hospital London

  STUDY CHAIR

Central Study Contacts

Katherine Lau

CONTACT

07738247830; katherine.lau@nhs.net

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: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 27, 2020
• Study Start: October 22, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)