Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies

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.

Conditions

• Hypertension in Pregnancy
• Hypertension
• Pregnancy

Interventions

DIETARY_SUPPLEMENT

Inorganic 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_SUPPLEMENT

Placebo 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.

Sponsors & Collaborators

• Hospital das Clínicas de Ribeirão Preto

  collaborator OTHER

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Ricardo C Cavalli, Dr · Medical School of Ribeirao Preto, USP

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-06

Primary Completion

2026-12-31

Completion

2027-07-31

Countries

• Brazil

Study Locations