Hypertension in PregnancyNCT04604535
The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy
A study testing Concentrated beetroot juice in people with Hypertension in Pregnancy and Pre-Eclampsia, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This is a randomised placebo controlled trial investigating the effects of dietary nitrate supplementation on hypertension in pregnancy Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension in Pregnancy, Pre-Eclampsia, Gestational Hypertension
- What is being tested?
- Concentrated beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Oct 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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
- 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 written informed consent
- Those who are detained as a prisoner or detained in any secured unit, including those held under the Mental Health Act
- Those not fluent in local language, and absence of appropriate interpreter despite use of services such as Language Line
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London
Katherine Lau, MBBS/BSc, 07738247830, katherine.lau@nhs.net
Nick Kametas, nkametas@nhs.net
About this study
Official title: The Effects of Dietary Nitrate Supplementation on Pregnancies Complicated by Chronic and New Onset Hypertension
This is a randomised placebo controlled trial investigating the effects of dietary nitrate supplementation on hypertension in pregnancy
Read the 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
- Being tested
- Concentrated beetroot juice, Placebo
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated beetroot juiceDietary supplement
70mL concentrated beetroot juice (400mg nitrate)
PlaceboDietary supplement
70mL concentrated nitrate deplete beetroot juice (<0.01mmol/L nitrate)
| Study group | Role | What they receive |
|---|---|---|
| Concentrated beetroot juice | Active comparator | 70mL of concentrated beetroot juice with 400mg nitrate Receives: Dietary Supplement: Concentrated beetroot juice |
| Placebo | Placebo comparator | 70mL of concentrated beetroot juice with <0.01mmol/L nitrate Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age of delivery secondary to preeclampsia
Measured: From recruitment until delivery
Secondary outcomes (8)
Gestational age of delivery (due to any cause)
Measured: From recruitment until delivery
Will beetroot juice supplementation increase or decrease the likelihood of maternal complications, including severe maternal complications
Measured: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation increase or decrease the likelihood of severe hypertension
Defined as ≥ 160/110 mmHg
Measured: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation result in significant changes in systolic blood pressure and diastolic blood pressure
Measured: 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
Measured: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation result in a significant change in maternal blood values and urinary protein excretion
Measured by creatinine, aspartate aminotransferase, alanine aminotransferase, uric acid, platelets, random urine protein creatinine ratio, protein concentration in a 24hour urine collection
Measured: From recruitment until 8 weeks postnatal
Can the safety of beetroot juice supplementation in pregnancy be confirmed
Measurement of maternal methemoglobinaemia levels, maternal nitrosamine levels, maternal thyroid function, neonatal cord bloods, neonatal methemoglobinaemia levels
Measured: From recruitment until 8 weeks postnatal
To confirm the acceptability of beetroot juice supplementation in pregnancy
A post-trial questionnaire
Measured: At 8 weeks postnatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start22 Oct 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Fetal Medicine Foundation, Barts and the London School of Medicine and Dentistry
- Responsible party
- Sponsor
- Investigators
- Nick Kametas, Study chair, Fetal Medicine Research Institute, King's College Hospital LondonKypros Nicolaides, Study chair, Fetal Medicine Research Institute, King's College Hospital London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604535
- Sponsor's protocol ID
- 263871
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Nitrate Supplementation on Pregnancies Complicated by Chronic and New Onset Hypertension
- ClinicalTrials.gov ID
- NCT04604535
- Acronym / sponsor ID
- 263871
- Conditions
- Hypertension in Pregnancy, Pre-Eclampsia, Gestational Hypertension, Pregnancy Induced Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Fetal Medicine Foundation, Barts and the London School of Medicine and Dentistry
- Study start
- 22 Oct 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentrated beetroot juice | Active comparator | Dietary Supplement: Concentrated beetroot juice70mL of concentrated beetroot juice with 400mg nitrate |
| Placebo | Placebo comparator | Dietary Supplement: Placebo70mL of concentrated beetroot juice with <0.01mmol/L nitrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentrated beetroot juice70mL concentrated beetroot juice (400mg nitrate) | Dietary supplement | Concentrated beetroot juice |
| Placebo70mL concentrated nitrate deplete beetroot juice (<0.01mmol/L nitrate) | Dietary supplement | Placebo |
Primary outcome
Gestational age of delivery secondary to preeclampsia
Time frame: From recruitment until delivery
8 secondary outcomes
Gestational age of delivery (due to any cause)
Time frame: From recruitment until delivery
Will beetroot juice supplementation increase or decrease the likelihood of maternal complications, including severe maternal complications
Time frame: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation increase or decrease the likelihood of severe hypertension
Time frame: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation result in significant changes in systolic blood pressure and diastolic blood pressure
Time frame: 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
Time frame: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation result in a significant change in maternal blood values and urinary protein excretion
Time frame: From recruitment until 8 weeks postnatal
Can the safety of beetroot juice supplementation in pregnancy be confirmed
Time frame: From recruitment until 8 weeks postnatal
To confirm the acceptability of beetroot juice supplementation in pregnancy
Time frame: At 8 weeks postnatal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Kametas study chair
Fetal Medicine Research Institute, King's College Hospital London
Kypros Nicolaides study chair
Fetal Medicine Research Institute, King's College Hospital London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated beetroot juice in people with Hypertension in Pregnancy and Pre-Eclampsia, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Lau (07738247830, katherine.lau@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age of delivery secondary to preeclampsia (time frame: From recruitment until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.