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| Name | Class |
|---|---|
| Westmead Institute for Medical Research | UNKNOWN |
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People with autosomal dominant polycystic kidney disease (ADPKD) develop high blood pressure and kidney disease. Previous studies have shown that a commonly occurring chemical, nitric oxide (NO), is reduced in ADPKD, and may contribute, in part, to high blood pressure in this condition. Nitrate is found in high concentrations naturally in beetroots, and increases NO. The aim of this study is to determine if beetroot juice reduces blood pressure in hypertensive people with ADPKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate-rich beetroot juice | Experimental | Beetroot juice containing naturally occurring nitrate (400mg total nitrate) |
|
| Nitrate-depleted beetroot juice | Placebo Comparator | Beetroot juice with nitrate removed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beetroot juice | Dietary Supplement | 70mls beetroot juice (400mg nitrate) given daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study) | Change in systolic and diastolic blood pressure over two time points - from readings taken at baseline (visit 1) compared with readings taken at 4 weeks (which was the end of the study; visit 3) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks | Reported change in blood pressure is average change per week, over 4 weeks | 4 weeks |
| Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G K Rangan | Westmead Hospital, Western Sydney Local Health District | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Sydney | New South Wales | 2145 | Australia | ||
| Westmead Institute for Medical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356039 | Derived | 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. | |
| 37507763 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Nitrate-depleted Beetroot Juice |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2023 |
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| Nitrate-depleted beetroot juice | Dietary Supplement | 70mls beetroot juice (nitrate-depleted) given daily for 4 weeks |
|
| 4 weeks |
| Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study) | 4 weeks |
| Change in Salivary Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study) | 4 weeks |
| Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study) | Asymmetric dimethylarginine (ADMA) which is a recognized marker of endothelial dysfunction and inhibitor of nitric oxide | 4 weeks |
| Westmead |
| New South Wales |
| 2145 |
| Australia |
| 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. |
Beetroot juice with nitrate removed
Nitrate-depleted beetroot juice: 70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Nitrate-depleted Beetroot Juice | Beetroot juice with nitrate removed Nitrate-depleted beetroot juice: 70mls beetroot juice (nitrate-depleted) given daily for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Self-reported ethnicity | Count of Participants | Participants |
| |||||||||||||||
| Employment status, categorical (Part time, Full time)) | Count of Participants | Participants |
| ||||||||||||||||
| Factor precipitating diagnosis, categorical (family history screening; pain; hypertension;incidental | Count of Participants | Participants |
| ||||||||||||||||
| Diagnosis confirmatory test (radiographic) | Count of Participants | Participants |
| ||||||||||||||||
| Age at diagnosis | Mean | Standard Deviation | years |
| |||||||||||||||
| Family history of ADPKD | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study) | Change in systolic and diastolic blood pressure over two time points - from readings taken at baseline (visit 1) compared with readings taken at 4 weeks (which was the end of the study; visit 3) | One patient in the nitrate-rich group was lost to follow-up. | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
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| Secondary | Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks | Reported change in blood pressure is average change per week, over 4 weeks | Posted | Mean | 95% Confidence Interval | mmHg/week | 4 weeks |
|
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| Secondary | Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study) | Posted | Median | Inter-Quartile Range | mg/mmol | 4 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study) | Posted | Median | Inter-Quartile Range | µM | 4 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Salivary Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study) | Not Posted | Dec 2028 | 4 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study) | Asymmetric dimethylarginine (ADMA) which is a recognized marker of endothelial dysfunction and inhibitor of nitric oxide | Posted | Median | Standard Deviation | umol/L | 4 weeks |
|
|
4 weeks (from enrollment to end of follow up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nitrate-rich Beetroot Juice | Beetroot juice containing naturally occurring nitrate (400mg total nitrate) | 0 | 29 | 0 | 29 | 18 | 29 |
| EG001 | Nitrate-depleted Beetroot Juice | Beetroot juice with nitrate removed | 0 | 30 | 0 | 30 | 11 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal symptoms (not serious adverse event) | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Change in bowel habit | Gastrointestinal disorders | Non-systematic Assessment | Includes all changes in bowel habit, including those perceived as positive changes |
| |
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Beeturia | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Beet-coloured faeces | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Gopala Rangan | Westmead Hospital and Westmead Institute for Medical Research | 8627 3000 | g.rangan@sydney.edu.au |
| May 7, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Asian |
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| Other |
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| Part time |
|
| Umemployed |
|
| Pain |
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| Hypertension |
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| Incidental |
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| Other |
|
| No |
|
| Unknown |
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