HypertensionNCT02520687
Effects of Dietary Nitrate in Hypertensive Pregnant Women
A study testing Beetroot juice and Nitrate-depleted beetroot juice in people with Hypertension and Pregnancy, run by University of Manchester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Hypertension, Pregnancy
- What is being tested?
- Beetroot juice and Nitrate-depleted beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Feb 2017
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multi-fetal pregnancy
- Currently taking anti-hypertensive medication
- Pre-existing diabetes (Type 1 or Type 2)
- Lacking ability to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Maternal and Fetal Health Research Centre
Manchester, M13 9WL
About this study
Official title: Feasibility Study on the Effects of Dietary Nitrate on Cardiovascular Function in Hypertensive Pregnant Women
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.
- Conditions
- Hypertension, Pregnancy
- Being tested
- Beetroot juice, Nitrate-depleted beetroot juice
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
70mls daily for seven days
Nitrate-depleted beetroot juiceDietary supplement
70mls daily for seven days
| Study group | Role | What they receive |
|---|---|---|
| Dietary nitrate, beetroot juice | Experimental | Once daily 70mL dose of beetroot juice, containing 400mg inorganic nitrate, for 7 consecutive days. Receives: Dietary Supplement: Beetroot juice |
| Nitrate-depleted beetroot juice | Placebo comparator | Once daily 70mL dose of beetroot juice, depleted of nitrate, for 7 consecutive days. Receives: Dietary Supplement: Nitrate-depleted beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinic blood pressure (compared to baseline) between treatment and placebo groups
Measured: The outcome will be determined after 7 days treatment (compared to baseline)
Secondary outcomes (5)
Recruitment rates
Measured: Across study (18 months)
Uterine artery blood flow (compared to baseline)
Measured: The outcome will be determined after 7 days treatment (compared to baseline)
Umbilical artery blood flow (compared to baseline)
Measured: The outcome will be determined after 7 days treatment (compared to baseline)
Changes in plasma and salivary nitrate concentrations
Measured: The outcome will be determined after 7 days treatment (compared to baseline)
Changes in plasma and salivary nitrite concentrations
Measured: The outcome will be determined after 7 days treatment (compared to baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Model description
- Dietary Nitrate
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jenny Myers, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520687
- Sponsor's protocol ID
- 15136
- Status last verified
- Apr 2025
- First submitted
- 5 Aug 2015
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Effects of Dietary Nitrate on Cardiovascular Function in Hypertensive Pregnant Women
- ClinicalTrials.gov ID
- NCT02520687
- Acronym / sponsor ID
- 15136
- Conditions
- Hypertension, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dietary Nitrate
| Arm | Type | Receives |
|---|---|---|
| Dietary nitrate, beetroot juice | Experimental | Dietary Supplement: Beetroot juiceOnce daily 70mL dose of beetroot juice, containing 400mg inorganic nitrate, for 7 consecutive days. |
| Nitrate-depleted beetroot juice | Placebo comparator | Dietary Supplement: Nitrate-depleted beetroot juiceOnce daily 70mL dose of beetroot juice, depleted of nitrate, for 7 consecutive days. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Multi-fetal pregnancy
- Currently taking anti-hypertensive medication
- Pre-existing diabetes (Type 1 or Type 2)
- Lacking ability to consent
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 |
|---|---|---|
| Beetroot juice70mls daily for seven days | Dietary supplement | Dietary nitrate, beetroot juice |
| Nitrate-depleted beetroot juice70mls daily for seven days | Dietary supplement | Nitrate-depleted beetroot juice |
Primary outcome
Change in clinic blood pressure (compared to baseline) between treatment and placebo groups
Time frame: The outcome will be determined after 7 days treatment (compared to baseline)
5 secondary outcomes
Recruitment rates
Time frame: Across study (18 months)
Uterine artery blood flow (compared to baseline)
Time frame: The outcome will be determined after 7 days treatment (compared to baseline)
Umbilical artery blood flow (compared to baseline)
Time frame: The outcome will be determined after 7 days treatment (compared to baseline)
Changes in plasma and salivary nitrate concentrations
Time frame: The outcome will be determined after 7 days treatment (compared to baseline)
Changes in plasma and salivary nitrite concentrations
Time frame: The outcome will be determined after 7 days treatment (compared to baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice and Nitrate-depleted beetroot juice in people with Hypertension and Pregnancy, run by University of Manchester 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 15 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinic blood pressure (compared to baseline) between treatment and placebo groups (time frame: The outcome will be determined after 7 days treatment (compared to baseline)). 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 15 Apr 2025.