Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease
NCT ID: NCT05401409
Last Updated: 2025-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-05-05
2023-03-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nitrate-rich beetroot juice
Beetroot juice containing naturally occurring nitrate (400mg total nitrate)
Beetroot juice
70mls beetroot juice (400mg nitrate) given daily for 4 weeks
Nitrate-depleted beetroot juice
Beetroot juice with nitrate removed
Nitrate-depleted beetroot juice
70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
Interventions
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Beetroot juice
70mls beetroot juice (400mg nitrate) given daily for 4 weeks
Nitrate-depleted beetroot juice
70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years old
* Estimated Glomerular Filtration Rate (eGFR) \> 30 mL/min/1.73m2
* Treatment with at least one anti-hypertensive
Exclusion Criteria
* Labile, unstable, uncontrolled hypertension and/or changes in BP treatment 28 days prior to the screening visit
* Non-compliance with study procedures and/or daily BP measurements during the screening period
* Medical conditions or treatments that might interfere with the generation of NO metabolites or the primary endpoint (e.g. nitrate drugs; cigarette smoking; unwilling to stop using antiseptic mouthwash; severe, uncontrolled hypercholesterolemia; pregnancy or post-partum and lactating)
* Any serious or other medical conditions that might interfere with follow-up or stability of blood pressure (e.g. current active malignancies; uncontrolled diabetes mellitus with elevated HbA1c \> 10%)
* Dislike of taste of beetroot juice
* Allergy to beetroot
* Enrolled in other clinical trials
18 Years
ALL
No
Sponsors
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Westmead Institute for Medical Research
UNKNOWN
Western Sydney Local Health District
OTHER
Responsible Party
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Gopala K. Rangan
Nephrologist
Principal Investigators
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G K Rangan
Role: PRINCIPAL_INVESTIGATOR
Westmead Hospital, Western Sydney Local Health District
Locations
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Westmead Hospital
Sydney, New South Wales, Australia
Westmead Institute for Medical Research
Westmead, New South Wales, Australia
Countries
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References
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St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
Sagar PS, Munt A, Saravanabavan S, Vahedi FA, Elhindi J, Nguyen B, Chau K, Harris DC, Lee V, Sud K, Wong N, Rangan GK. Efficacy of beetroot juice on reducing blood pressure in hypertensive adults with autosomal dominant polycystic kidney disease (BEET-PKD): study protocol for a double-blind, randomised, placebo-controlled trial. Trials. 2023 Jul 29;24(1):482. doi: 10.1186/s13063-023-07519-2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020_ETH01718
Identifier Type: -
Identifier Source: org_study_id
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