Beetroot Juice Supplementation in Chronic Hypertensive Pregnancies — BEET_CH  

Hypertension Clinical Trial

Official title: Beetroot Juice Supplementation for Blood Pressure Management in Chronic Hypertensive Pregnancies From the 2nd Trimester (BBET_CH): a Triple-Blind, Randomized, Placebo-Controlled Trial

Status Recruiting

Clinical Trial 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 beetroot might be a safer alternative. The efficacy of beetroot is attributed to its ability to stimulate the body's production of a natural 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 beetroot supplements, 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. The study aims to delve deeper by evaluating the effects of beetroot juice on pregnant women from the beginning of pregnancy and continuing it throughout the term. If the results are positive, beetroot could revolutionize the approach to blood pressure management during pregnancy, paving the way for healthier futures for both mothers and their babies.

Clinical Trial Description

Eligible hypertensive pregnant women will be identified and approached for participation by medical professionals within the municipality's health network, based on the inclusion criteria. An appointment will be promptly scheduled to verify eligibility and present the informed consent form, during which all questions and concerns will be addressed.

On the enrollment day, the subsequent visit will be scheduled for the 16th week of their pregnancy, marking the commencement of the study. By then, participants will already have been randomly allocated to respective groups by an external professional, not directly involved in the study, ensuring blinding. Randomization will occur on a 1:1 ratio, employing blocks of 2-4 pregnant women as determined by specialized software. Regardless of allocation, participants will continue with standard medications for pre-eclampsia prophylaxis: acetylsalicylic acid, taken at 100 mg nightly up to 36 weeks of gestation, and calcium carbonate, taken at 1000 mg daily until delivery, alongside routine antihypertensive treatment.

From the 16th week of pregnancy onward, participants will either receive a shot of nitrate-enriched concentrated beetroot extract (Beet-It Sport®; James White Drinks Co, UK), or an equivalent placebo. All participants will be instructed to consume the entire content (70ml) each morning, continuing this regimen for a period of 22 weeks (154 days), ending either at the 38th week of pregnancy or childbirth, whichever occurs first.

Visits will take place at predetermined intervals based on the progression of the pregnancy. Initially set at a frequency of every 4 weeks, but as the end of the pregnancy approaches, the visits will become more frequent. The baseline appointment is set for the 16th week of gestation, with subsequent appointments scheduled for the 20th, 24th, 28th, 32nd, 34th, 36th, 37th, and 38th weeks. It is important to note that scheduled visits may conclude earlier if childbirth occurs sooner, or they might be extended if the pregnancy progresses beyond the anticipated delivery date. During these visits, participants will undergo an obstetric clinical examination, blood pressure measurement, biochemical analysis, and an ultrasound paired with a Doppler study of the uterine arteries.

To ensure consistent and optimal blood pressure levels, the overseeing medical team will closely monitor and adjust participants' antihypertensive medications as necessary. Ensuring adherence to the regimen is paramount; thus, participants will be asked to return any unused shots during their visits and will then be supplied with the next batch for the ensuing period. ;

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pregnancy

• NCT number: NCT06105775
• Study type: Interventional
• Source: University of Sao Paulo
• Contact: Ricardo C Cavalli, Dr
• Phone: +55166021000
• Email: rcavalli@fmrp.usp.br
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Completion date: March 2025