Hypertension in PregnancyNIT_CHNCT06105775
Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies
A study testing Inorganic Nitrate Capsule in people with Hypertension in Pregnancy and Hypertension, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
High blood pressure during pregnancy poses significant risks to both the mother and baby. A combination of factors, including advancing maternal age, rising obesity rates, and metabolic health issues, have amplified the prevalence of this condition. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension in Pregnancy, Hypertension, Pregnancy
- What is being tested?
- Inorganic Nitrate Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Mar 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women diagnosed with chronic hypertension (systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg before pregnancy or before 20 weeks of gestation) as defined by the Brazilian Network for Studies on Hypertension in Pregnancy (RBEHG, Brazilian acronym) Protocol and Chronic Hypertension/Preeclampsia by the Brazilian Federation of Gynecology and Obstetrics Associations (FEBRASGO, Brazilian acronym) Protocol.
- Patients on monotherapy with methyldopa as treatment at the time of inclusion.
- Women with less than 16 weeks of gestation confirmed by first-trimester ultrasonography confirming gestational age.
Who cannot join
- Multiple pregnancies, age below 18 years old, inability to provide informed consent, or history of low adherence to medication therapy.
- Patients with uncontrolled chronic hypertension, with blood pressure values above 160x110mmHg.
- History of food allergies, especially hypersensitivity to beetroot.
- Users of illicit drugs, smokers, or alcohol abusers.
- Diagnosis of coronary artery disease, congestive heart failure (moderate to severe), moderate to severe liver failure, chronic renal insufficiency (with plasma creatinine clearance less than 30 ml/min/1.73 m² of body surface), pre-existing type 1 diabetes, and type 2 diabetes.
- Pregnant women who frequently used non-steroidal anti-inflammatory drugs, nasal decongestants, and anorectics before getting pregnant; users of proton pump inhibitors and H2 receptor antagonists or any other medication that interferes with stomach pH, starting 2 weeks before the beginning and continuing throughout the remainder of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo
PRISCILA O BARBOSA, Dr, +5531971349289, barbosapo@usp.br
RICARDO C CAVALLI, Dr
About this study
Official title: Inorganic Nitrate Supplementation for Blood Pressure Control in Chronic Hypertensive Pregnancies From the 2nd Trimester (NIT_CH): a Triple-Blind Randomized Placebo-Controlled Trial
High blood pressure during pregnancy poses significant risks to both the mother and baby. A combination of factors, including advancing maternal age, rising obesity rates, and metabolic health issues, have amplified the prevalence of this condition. While conventional medicines are available, safety during pregnancy remains a concern. Recent studies suggest that inorganic nitrate might be a safer alternative. The power of nitrate lies in its ability to stimulate the body's production of a compound that aids in dilating and relaxing blood vessels. Preliminary studies conducted on mice and a select group of pregnant women have yielded encouraging results. Early tests indicated that after consuming inorganic nitrate, there was a reduction in blood pressure and an improvement in the health of the mother's uterine artery-a vital vessel responsible for nourishing the fetus. Our study aims to investigate the effects of inorganic nitrate supplementation on pregnant women from the start of their pregnancy and continuing it throughout their term. If our findings are positive, it could revolutionize how we approach blood pressure management during pregnancy, paving the way for healthier futures for both mothers and babies.
Read the detailed description
Eligible pregnant women with chronic hypertension will be identified and invited to participate through posters displayed in the municipality's health units, as well as by medical professionals within the local health network, based on the inclusion criteria. An appointment will be promptly scheduled to verify eligibility and present the informed consent form, during which all questions and concerns will be addressed.
On the enrollment day, the subsequent visit will be scheduled for the 16th week of their pregnancy, marking the commencement of the study. By then, participants will already have been randomly allocated to respective groups by an external professional who is not directly involved in the study, ensuring blinding. Randomization will occur on a 1:1 ratio, employing blocks of 2-4 pregnant women as determined by specialized software. Regardless of allocation, participants will continue with standard medications for preeclampsia prophylaxis: acetylsalicylic acid, taken at 100 mg nightly up to 36 weeks of gestation, and calcium carbonate, taken at 1000 mg daily until delivery, alongside routine antihypertensive treatment.
From the 16th week of pregnancy onward, participants will receive either a capsule containing 400 mg of inorganic nitrate (540 mg of sodium nitrate, equivalent to 140 mg of sodium chloride and 400 mg of nitrate) or a placebo (140 mg of sodium chloride and 400 mg of flour). Both capsules will be identical in color and appearance. All participants will be instructed to take one capsule each morning, continuing this regimen for 22 weeks (154 days), ending either at the 38th week of pregnancy or at childbirth, whichever occurs first.
Visits will take place at predetermined intervals based on the progression of the pregnancy. Initially set at a frequency of every 4 weeks, but as the end of the pregnancy approaches, the visits will become more frequent. The baseline appointment is set for the 16th week of gestation, with subsequent appointments scheduled for the 20th, 24th, 28th, 32nd, 34th, 36th, 37th, and 38th weeks. It is important to note that scheduled visits may conclude earlier if childbirth occurs sooner, or they might be extended if the pregnancy progresses beyond the anticipated delivery date. During these visits, participants will undergo an obstetric clinical examination, blood pressure measurement, biochemical analysis, and an ultrasound paired with a Doppler study of the uterine arteries.
To ensure consistent and optimal blood pressure levels, the overseeing medical team will closely monitor and adjust participants' antihypertensive medications as necessary. Ensuring adherence to the regimen is paramount; thus, participants will be asked to return any unused capsules during their visits and will then be supplied with their next batch for the ensuing period.
- Conditions
- Hypertension in Pregnancy, Hypertension, Pregnancy
- Being tested
- Inorganic Nitrate Capsule, Placebo Capsule
- Keywords
- Endothelial Dysfunction, Hypertension in Pregnancy, Nitric Oxide, inorganic nitrate
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inorganic Nitrate CapsuleDietary supplement
Starting from the 16th week of gestation and continuing for 22 weeks (154 days) or until delivery, whichever comes first, participants will consume a daily capsule containing 400 mg of inorganic nitrate. Participants will maintain standard preeclampsia prophylaxis (acetylsalicylic acid 100mg nightly until 36 weeks of gestation and calcium carbonate 1000mg daily until delivery) and regular antihypertensive treatment.
Placebo CapsuleDietary supplement
From the 16th week of gestation and lasting 22 weeks (154 days) or until delivery, participants will consume a daily capsule containing sodium chloride with the nitrate replaced by plant-based flour, design to mimic the appearance of the active capsule. Participants will maintain standard preeclampsia prophylaxis (acetylsalicylic acid 100mg nightly until 36 weeks of gestation and calcium carbonate 1000mg daily until delivery) and regular antihypertensive treatment.
| Study group | Role | What they receive |
|---|---|---|
| Inorganic Nitrate Capsule | Experimental | Once daily capsule containing sodium nitrate (400 mg of nitrate and 140 mg of sodium), for 154 consecutive days. Receives: Dietary Supplement: Inorganic Nitrate Capsule |
| Placebo Capsule. | Placebo comparator | Once daily capsule containing sodium chloride (140 mg of sodium chloride and 400 mg of flour), for 154 consecutive days. Receives: Dietary Supplement: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Control in Chronic Hypertensive Pregnant Women with Inorganic Nitrate Supplementation Compared to Placebo.
Blood pressure will be assessed using semiautomatic equipment, measuring systolic and diastolic pressures in millimeters of mercury (mmHg). Ambulatory Blood Pressure Monitoring (ABMP) will be employed at the beginning of the clinical trial. Lower readings indicate better blood pressure control, while higher readings suggest poorer control.
Measured: From baseline (16th week) up to delivery
Increased Antihypertensive Medication Requirements in Patient Groups
The investigators will monitor both the inorganic nitrate group and the placebo group for any need to increase the dosage of antihypertensive medications, frequency or introduce a new agent.
Measured: From baseline (16th week) up to delivery
Secondary outcomes (12)
Doppler Analysis of Maternal and Fetal Vessel Behavior Across Pregnancy in Both Groups
Using Doppler velocimetry, the investigators will evaluate fetal vessels, focusing on the middle cerebral artery and umbilical artery. These tests will be conducted with mothers resting in left lateral decubitus during fetal rest periods, excluding respiratory movements. Key parameters, including the systole/diastole (A/B) ratios, resistance index, and pulsatility index, will be captured. Concurrently, maternal Doppler velocimetry of the uterine artery and pulse wave velocity will be measured to assess arterial stiffness.
Measured: From baseline (16th week) up to delivery
Fetal Growth Assessment and Incidence of Fetal Growth Restriction in Both Groups
Fetal growth will be assessed using biometric measurements and evaluations like the fetal biophysical profile, placental maturity grade, and amniotic fluid evaluations. Key biometric parameters include biparietal diameter, cranial circumference, abdominal circumference, femur length, and estimated fetal weight (EFW). The "Hadlock" formula will help determine EFW, classifying the fetus as small for gestational age, average or large for gestational age. The biophysical profile will give insights into fetal movements and conditions over a 30-minute period. Placental maturity and amniotic fluid status will further provide context to the overall fetal health and growth.
Measured: From baseline (16th week) up to delivery
Incidence of Preeclampsia Overlap and Adverse Maternal Outcomes in Each Group
Clinical data will be collected to evaluate the presence of preeclampsia overlap and any associated adverse maternal outcomes. The collected data will include the gestational age at the time of delivery (in weeks + days), type of delivery (vaginal or cesarean), and specific clinical outcomes related to the mother's health
Measured: At the time of delivery
Incidence of Perinatal Outcomes
Post childbirth, perinatal outcomes will be assessed by recording essential metrics of the newborn. The collected data will include the newborn's gender, weight (measured in grams), length (measured in cm), and the Apgar scores documented at both the first- and fifth minutes post-birth.
Measured: Immediately after delivery.
Vascular Reactivity of the Umbilical Artery In Vitro in Both Groups After Delivery
Umbilical cord fragments will b collected for evaluation. The fragments will be used to assess vascular tone changes in the umbilical artery using isometric force transducers. The viability and reactivity of the vessel rings will be determined using specific stimuli such as potassium chloride (KCl) and serotonin.
Measured: Approximately 15 to 30 minutes post-delivery, with some additional time for the in vitro evaluations.
Evaluation of Complete Blood Count, Lipid and Glycemic Profiles, and Fasting Insulin Levels in Each Group
Participants' overall health will be evaluated through a series of blood tests, including complete blood count, glucose and insulin levels, creatinine, urea, liver enzymes, serum bilirubins and lipid profile.
Measured: From baseline (16th week) up to delivery
Evaluation of Nitric Oxide Metabolite Concentrations in Plasma, Urine, and Saliva in Each Group
The concentrations of nitrate and nitrite, as key metabolites of nitric oxide, will be assessed in participants' plasma, urine, and saliva samples. The determination will be done using the Sievers Nitric Oxide Analyzer
Measured: From baseline (16th week) up to delivery
Evaluation of Serum Markers for Preeclampsia in Each Group
The risk of developing preeclampsia will be assessed by calculating the soluble fms-like tyrosine kinase (sFLT-1) and placenta growth factor (PlGF) ratio using serum values of the angiogenic factors PlGF and sFLT-1. This ratio provides an indication of the likelihood of preeclampsia onset within specified time frames or the presence of placental insufficiency.
Measured: From baseline (16th week) up to delivery
Evaluation of Inflammatory Markers in Each Group
Serum concentrations of various inflammatory markers, including adiponectin, intercellular adhesion molecule 1 (ICAM-1), interleukin-6 (IL6), interleukin-8 (IL8), interleukin-10 (IL10), leptin, resistin, tumor necrosis factor-alpha (TNFa), vascular cell adhesion molecule 1 (VCAM-1), vascular endothelial growth factor (VEGF), and visfatin, will be determined to evaluate inflammatory status in the participants.
Measured: From baseline (16th week) up to delivery
Evaluation of Oxidative Stress Markers in Each Group
The extent of lipid peroxidation will be represented by plasma levels of malondialdehyde (MDA). Lower MDA levels suggest decreased oxidative damage. Simultaneously, the overall antioxidant activity in the plasma will be gauged through the ferric-reducing ability of plasma (FRAP). Elevated FRAP values indicate a heightened ability to resist oxidative stress.
Measured: From baseline (16th week) up to delivery
Evaluation of Matrix Metalloproteinases and Inhibitors in Each Group
Serum concentrations of matrix metalloproteinases (MMPs) 2 and 9, as well as their inhibitors tissue inhibitor of metalloproteinases (TIMPs) 1 through 4, will be determined.
Measured: From baseline (16th week) up to delivery
Evaluation of Diet Quality in Each Group Using the SISVAN Protocol
The quality of participants' diets will be assessed using a standardized SISVAN protocol. Concurrently, dietary recalls will be employed to provide a detailed account of participants' food consumption and nutritional patterns.
Measured: The SISVAN protocol will be employed at the enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start6 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto
- Responsible party
- Principal investigator, Ricardo de Carvalho Cavalli, University of Sao Paulo
- Investigators
- Ricardo C Cavalli, Dr, Principal investigator, Medical School of Ribeirao Preto, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105775
- Sponsor's protocol ID
- 21/12010-7-SP2
- Acronym
- NIT_CH
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliveira Barbosa P, Aniceto V, Lima-Junior LS, de Souza Costa A, Tanus-Santos JE, Sandrim VC, Carvalho Cavalli R. NIT_CH: A study protocol for evaluating the effect of inorganic nitrate capsules in chronic hypertensive pregnancies - a triple-blind placebo-controlled randomized trial. BMC Pregnancy Childbirth. 2026 Jan 9;26(1):136. doi: 10.1186/s12884-025-08596-8.
PubMed 41514223
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inorganic Nitrate Supplementation for Blood Pressure Control in Chronic Hypertensive Pregnancies From the 2nd Trimester (NIT_CH): a Triple-Blind Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06105775
- Acronym / sponsor ID
- NIT_CH / 21/12010-7-SP2
- Conditions
- Hypertension in Pregnancy, Hypertension, Pregnancy
- Keywords
- Endothelial Dysfunction, Hypertension in Pregnancy, Nitric Oxide, inorganic nitrate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Oct 2023 (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.
High blood pressure during pregnancy poses significant risks to both the mother and baby. A combination of factors, including advancing maternal age, rising obesity rates, and metabolic health issues, have amplified the prevalence of this condition. While conventional medicines are available, safety during pregnancy remains a concern. Recent studies suggest that inorganic nitrate might be a safer alternative. The power of nitrate lies in its ability to stimulate the body's production of a compound that aids in dilating and relaxing blood vessels. Preliminary studies conducted on mice and a select group of pregnant women have yielded encouraging results. Early tests indicated that after consuming inorganic nitrate, there was a reduction in blood pressure and an improvement in the health of the mother's uterine artery-a vital vessel responsible for nourishing the fetus. Our study aims to investigate the effects of inorganic nitrate supplementation on pregnant women from the start of their pregnancy and continuing it throughout their term. If our findings are positive, it could revolutionize how we approach blood pressure management during pregnancy, paving the way for healthier futures for both mothers and babies.
Detailed description
Eligible pregnant women with chronic hypertension will be identified and invited to participate through posters displayed in the municipality's health units, as well as by medical professionals within the local health network, based on the inclusion criteria. An appointment will be promptly scheduled to verify eligibility and present the informed consent form, during which all questions and concerns will be addressed.
On the enrollment day, the subsequent visit will be scheduled for the 16th week of their pregnancy, marking the commencement of the study. By then, participants will already have been randomly allocated to respective groups by an external professional who is not directly involved in the study, ensuring blinding. Randomization will occur on a 1:1 ratio, employing blocks of 2-4 pregnant women as determined by specialized software. Regardless of allocation, participants will continue with standard medications for preeclampsia prophylaxis: acetylsalicylic acid, taken at 100 mg nightly up to 36 weeks of gestation, and calcium carbonate, taken at 1000 mg daily until delivery, alongside routine antihypertensive treatment.
From the 16th week of pregnancy onward, participants will receive either a capsule containing 400 mg of inorganic nitrate (540 mg of sodium nitrate, equivalent to 140 mg of sodium chloride and 400 mg of nitrate) or a placebo (140 mg of sodium chloride and 400 mg of flour). Both capsules will be identical in color and appearance. All participants will be instructed to take one capsule each morning, continuing this regimen for 22 weeks (154 days), ending either at the 38th week of pregnancy or at childbirth, whichever occurs first.
Visits will take place at predetermined intervals based on the progression of the pregnancy. Initially set at a frequency of every 4 weeks, but as the end of the pregnancy approaches, the visits will become more frequent. The baseline appointment is set for the 16th week of gestation, with subsequent appointments scheduled for the 20th, 24th, 28th, 32nd, 34th, 36th, 37th, and 38th weeks. It is important to note that scheduled visits may conclude earlier if childbirth occurs sooner, or they might be extended if the pregnancy progresses beyond the anticipated delivery date. During these visits, participants will undergo an obstetric clinical examination, blood pressure measurement, biochemical analysis, and an ultrasound paired with a Doppler study of the uterine arteries.
To ensure consistent and optimal blood pressure levels, the overseeing medical team will closely monitor and adjust participants' antihypertensive medications as necessary. Ensuring adherence to the regimen is paramount; thus, participants will be asked to return any unused capsules during their visits and will then be supplied with their next batch for the ensuing period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inorganic Nitrate Capsule | Experimental | Dietary Supplement: Inorganic Nitrate CapsuleOnce daily capsule containing sodium nitrate (400 mg of nitrate and 140 mg of sodium), for 154 consecutive days. |
| Placebo Capsule. | Placebo comparator | Dietary Supplement: Placebo CapsuleOnce daily capsule containing sodium chloride (140 mg of sodium chloride and 400 mg of flour), for 154 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women diagnosed with chronic hypertension (systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg before pregnancy or before 20 weeks of gestation) as defined by the Brazilian Network for Studies on Hypertension in Pregnancy (RBEHG, Brazilian acronym) Protocol and Chronic Hypertension/Preeclampsia by the Brazilian Federation of Gynecology and Obstetrics Associations (FEBRASGO, Brazilian acronym) Protocol.
- Patients on monotherapy with methyldopa as treatment at the time of inclusion.
- Women with less than 16 weeks of gestation confirmed by first-trimester ultrasonography confirming gestational age.
Key exclusion criteria (6 listed)
- Multiple pregnancies, age below 18 years old, inability to provide informed consent, or history of low adherence to medication therapy.
- Patients with uncontrolled chronic hypertension, with blood pressure values above 160x110mmHg.
- History of food allergies, especially hypersensitivity to beetroot.
- Users of illicit drugs, smokers, or alcohol abusers.
- Diagnosis of coronary artery disease, congestive heart failure (moderate to severe), moderate to severe liver failure, chronic renal insufficiency (with plasma creatinine clearance less than 30 ml/min/1.73 m² of body surface), pre-existing type 1 diabetes, and type 2 diabetes.
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 |
|---|---|---|
| Inorganic Nitrate CapsuleStarting from the 16th week of gestation and continuing for 22 weeks (154 days) or until delivery, whichever comes first, participants will consume a daily capsule containing 400 mg of inorganic nitrate. Participants will maintain standard preeclampsia prophylaxis (acetylsalicylic acid 100mg nightly until 36 weeks of gestation and calcium carbonate 1000mg daily until delivery) and regular antihypertensive treatment. | Dietary supplement | Inorganic Nitrate Capsule |
| Placebo CapsuleFrom the 16th week of gestation and lasting 22 weeks (154 days) or until delivery, participants will consume a daily capsule containing sodium chloride with the nitrate replaced by plant-based flour, design to mimic the appearance of the active capsule. Participants will maintain standard preeclampsia prophylaxis (acetylsalicylic acid 100mg nightly until 36 weeks of gestation and calcium carbonate 1000mg daily until delivery) and regular antihypertensive treatment. | Dietary supplement | Placebo Capsule. |
Primary outcome
Blood Pressure Control in Chronic Hypertensive Pregnant Women with Inorganic Nitrate Supplementation Compared to Placebo.
Time frame: From baseline (16th week) up to delivery
Blood pressure will be assessed using semiautomatic equipment, measuring systolic and diastolic pressures in millimeters of mercury (mmHg). Ambulatory Blood Pressure Monitoring (ABMP) will be employed at the beginning of the clinical trial. Lower readings indicate better blood pressure control, while higher readings suggest poorer control.
Increased Antihypertensive Medication Requirements in Patient Groups
Time frame: From baseline (16th week) up to delivery
The investigators will monitor both the inorganic nitrate group and the placebo group for any need to increase the dosage of antihypertensive medications, frequency or introduce a new agent.
12 secondary outcomes
Doppler Analysis of Maternal and Fetal Vessel Behavior Across Pregnancy in Both Groups
Time frame: From baseline (16th week) up to delivery
Fetal Growth Assessment and Incidence of Fetal Growth Restriction in Both Groups
Time frame: From baseline (16th week) up to delivery
Incidence of Preeclampsia Overlap and Adverse Maternal Outcomes in Each Group
Time frame: At the time of delivery
Incidence of Perinatal Outcomes
Time frame: Immediately after delivery.
Vascular Reactivity of the Umbilical Artery In Vitro in Both Groups After Delivery
Time frame: Approximately 15 to 30 minutes post-delivery, with some additional time for the in vitro evaluations.
Evaluation of Complete Blood Count, Lipid and Glycemic Profiles, and Fasting Insulin Levels in Each Group
Time frame: From baseline (16th week) up to delivery
Evaluation of Nitric Oxide Metabolite Concentrations in Plasma, Urine, and Saliva in Each Group
Time frame: From baseline (16th week) up to delivery
Evaluation of Serum Markers for Preeclampsia in Each Group
Time frame: From baseline (16th week) up to delivery
Evaluation of Inflammatory Markers in Each Group
Time frame: From baseline (16th week) up to delivery
Evaluation of Oxidative Stress Markers in Each Group
Time frame: From baseline (16th week) up to delivery
Evaluation of Matrix Metalloproteinases and Inhibitors in Each Group
Time frame: From baseline (16th week) up to delivery
Evaluation of Diet Quality in Each Group Using the SISVAN Protocol
Time frame: The SISVAN protocol will be employed at the enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 41514223Oliveira Barbosa P, Aniceto V, Lima-Junior LS, de Souza Costa A, Tanus-Santos JE, Sandrim VC, Carvalho Cavalli R. NIT_CH: A study protocol for evaluating the effect of inorganic nitrate capsules in chronic hypertensive pregnancies - a triple-blind placebo-controlled randomized trial. BMC Pregnancy Childbirth. 2026 Jan 9;26(1):136. doi: 10.1186/s12884-025-08596-8.
- 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.
Ricardo C Cavalli, Dr principal investigator
Medical School of Ribeirao Preto, USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inorganic Nitrate Capsule in people with Hypertension in Pregnancy and Hypertension, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo C Cavalli, Dr (+55166021000 ext. 2583, rcavalli@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Control in Chronic Hypertensive Pregnant Women with Inorganic Nitrate Supplementation Compared to Placebo. (time frame: From baseline (16th week) up to delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06105775, which also lists 1 linked publication.
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 20 Apr 2026.