Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06105775

Inorganic Nitrate Supplementation for Blood Pressure Control in Chronic Hypertensive Pregnancies From the 2nd Trimester (NIT_CH) A Triple-Blind Randomized Placebo-Controlled Trial

Led by University of Sao Paulo · Updated on 2026-04-20

144

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

U

University of Sao Paulo

Lead Sponsor

H

Hospital das Clínicas de Ribeirão Preto

Collaborating Sponsor

AI-Summary

What this Trial Is About

High blood pressure during pregnancy can pose serious risks to both mother and baby. This research aims to explore whether inorganic nitrate supplementation, which may help relax and widen blood vessels, can improve blood pressure control in pregnant women with chronic hypertension. Preliminary studies in animals and small groups of pregnant women have shown promising results, motivating this detailed investigation starting in the second trimester. Participants will be randomly assigned to receive either a daily capsule containing inorganic nitrate or a placebo, starting from the 16th week of pregnancy and continuing for 22 weeks or until delivery. All participants will continue standard medication for preeclampsia prevention, including low-dose aspirin and calcium carbonate, as well as their regular blood pressure treatments. The study uses a triple-blind design, and capsules for both groups look identical. During the study, participants will attend regular visits roughly every 4 weeks initially, increasing in frequency as delivery approaches. At these visits, they will undergo clinical exams, blood pressure checks, blood and urine tests, and ultrasound with Doppler studies of uterine arteries. Medication adjustments will be made as needed to maintain proper blood pressure. Researchers will monitor various health markers and pregnancy outcomes from the 16th week until delivery, ensuring close follow-up throughout the pregnancy period.

CONDITIONS

Brief Title

Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women diagnosed with chronic hypertension before pregnancy or before 20 weeks of gestation
  • Currently treated with methyldopa as monotherapy
  • Less than 16 weeks of gestation confirmed by first-trimester ultrasound
  • Female participants aged 18 years or older
Not Eligible

You will not qualify if you...

  • Multiple pregnancies
  • Age below 18 years
  • Unable to provide informed consent
  • History of poor adherence to medication
  • Uncontrolled chronic hypertension with blood pressure above 160/110 mmHg
  • Food allergies, especially to beetroot
  • Use of illicit drugs, smoking, or alcohol abuse
  • Coronary artery disease or moderate to severe heart failure
  • Moderate to severe liver failure
  • Chronic kidney failure with creatinine clearance below 30 ml/min/1.73 m²
  • Pre-existing type 1 or type 2 diabetes
  • Frequent use of certain medications affecting stomach pH or nasal decongestants before and during the study period

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 22 weeks (154 days) or until delivery

Participants take one daily capsule containing either inorganic nitrate or placebo starting from the 16th week of pregnancy. They continue this regimen alongside standard preeclampsia prophylaxis and antihypertensive treatment until the 38th week of pregnancy or delivery, whichever comes first.

9 visits scheduled at the 16th, 20th, 24th, 28th, 32nd, 34th, 36th, 37th, and 38th weeks of pregnancy, with frequency increasing as pregnancy progresses

Trial Site Locations

Total: 1 location

1

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

Ribeirão Preto, São Paulo, Brazil

Actively Recruiting

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Research Team

R

Ricardo C Cavalli, Dr

P

Priscila O Barbosa, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

NIT_CH: A study protocol for evaluating the effect of inorganic nitrate capsules in chronic hypertensive pregnancies - a triple-blind placebo-controlled randomized trial.

Priscila Oliveira Barbosa, Vinícius Aniceto, Luiz Sérgio Lima-Júnior...

https://pubmed.ncbi.nlm.nih.gov/41514223