NCT06105775 Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies
| NCT ID | NCT06105775 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Hypertension in Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2025-03-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Ricardo C Cavalli, Dr
PRINCIPAL INVESTIGATOR
Medical School of Ribeirao Preto, USP
Frequently Asked Questions
Who can join the NCT06105775 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hypertension in Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06105775 currently recruiting?
Yes, NCT06105775 is actively recruiting participants. Contact the research team at rcavalli@fmrp.usp.br for enrollment information.
Where is the NCT06105775 trial being conducted?
This trial is being conducted at Ribeirão Preto, Brazil.
Who is sponsoring the NCT06105775 clinical trial?
NCT06105775 is sponsored by University of Sao Paulo. The principal investigator is Ricardo C Cavalli, Dr at Medical School of Ribeirao Preto, USP. The trial plans to enroll 144 participants.