RecruitingNot ApplicableNCT06105775

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


Sponsor

University of Sao Paulo

Enrollment

144 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Brazilian trial is testing whether inorganic nitrate supplements (derived from beets/vegetables) can help lower blood pressure and improve pregnancy outcomes in women who have chronic hypertension (high blood pressure that existed before pregnancy) and are already being treated with methyldopa. **You may be eligible if...** - You are a pregnant woman diagnosed with chronic hypertension before pregnancy or before 20 weeks gestation - You are currently being treated with methyldopa only (no other blood pressure medications) - You are less than 16 weeks pregnant (confirmed by first-trimester ultrasound) **You may NOT be eligible if...** - You are pregnant with multiples (twins, triplets, etc.) - You are under 16 years old - Your blood pressure is severely uncontrolled (above 160/110 mmHg) - You have a food allergy, especially to beetroot - You smoke, use illegal drugs, or drink heavily - You have coronary artery disease, heart failure, severe liver or kidney disease, or pre-existing diabetes - You regularly use NSAIDs (like ibuprofen), nasal decongestants, or medications that affect stomach acid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTInorganic Nitrate Capsule

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.

DIETARY_SUPPLEMENTPlacebo Capsule

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.


Locations(1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, São Paulo, Brazil

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NCT06105775


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