NCT06105775Recruiting
Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies
Inorganic Nitrate Supplementation for Blood Pressure Control in Chronic Hypertensive Pregnancies From the 2nd Trimester (NIT_CH): a Triple-Blind Randomized Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 23 Oct 2023
- Start date
- 6 Mar 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Sao Paulo
- Diseases
- High blood pressure
- NCT number
- NCT06105775
What you commit to
- Study type: Interventional
- Planned participants: 144
- From 6 Mar 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Users of illicit drugs, smokers, or alcohol abusers.
- 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.
Other illness
- Patients with uncontrolled chronic hypertension, with blood pressure values above 160x110mmHg.
- History of food allergies, especially hypersensitivity to beetroot.
Lab values
- 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.
Age
- Multiple pregnancies, age below 18 years old, inability to provide informed consent, or history of low adherence to medication therapy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
Related publications
- 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 · PMID 41514223
This page is information, not medical advice. Discuss any trial with your doctor.