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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
RECRUITING
Ribeirão Preto
Contact Information
Primary
Ricardo C Cavalli, Dr
rcavalli@fmrp.usp.br
+55166021000
Backup
Priscila O Barbosa, Dr
barbosapo@usp.br
+5531971349289
Time Frame
Start Date: 2025-03-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 144
Treatments
Experimental: Inorganic Nitrate Capsule
Once daily capsule containing sodium nitrate (400 mg of nitrate and 140 mg of sodium), for 154 consecutive days.
Placebo_comparator: Placebo Capsule.
Once daily capsule containing sodium chloride (140 mg of sodium chloride and 400 mg of flour), for 154 consecutive days.
Sponsors
Leads: University of Sao Paulo
Collaborators: Hospital das Clínicas de Ribeirão Preto

This content was sourced from clinicaltrials.gov