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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05401409




Registration number
NCT05401409
Ethics application status
Date submitted
27/05/2022
Date registered
2/06/2022
Date last updated
1/05/2023

Titles & IDs
Public title
Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease
Scientific title
Double-Blind, Randomised Placebo-Controlled Study to Determine the Effect of Beetroot Juice on Reducing Blood Pressure in Hypertensive Adults With Autosomal Dominant Polycystic Kidney Disease
Secondary ID [1] 0 0
2020_ETH01718
Universal Trial Number (UTN)
Trial acronym
BEET-PKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autosomal Dominant Polycystic Kidney 0 0
Hypertension 0 0
Endothelial Dysfunction 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Beetroot juice
Other interventions - Nitrate-depleted beetroot juice

Experimental: Nitrate-rich beetroot juice - Beetroot juice containing naturally occurring nitrate (400mg total nitrate)

Placebo Comparator: Nitrate-depleted beetroot juice - Beetroot juice with nitrate removed


Other interventions: Beetroot juice
70mls beetroot juice (400mg nitrate) given daily for 4 weeks

Other interventions: Nitrate-depleted beetroot juice
70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in clinic systolic and diastolic blood pressure from baseline until end of study
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Change in daily home systolic and diastolic blood pressure from baseline until the end of the study
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Change in urinary albumin to creatinine ratio from baseline until the end of the study
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Change in serum nitrate/nitrite levels from baseline until the end of the study
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Change in salivary nitrate/nitrite levels from baseline until the end of the study
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Change in serum asymmetric dimethylarginine from baseline until the end of the study
Timepoint [5] 0 0
4 weeks

Eligibility
Key inclusion criteria
- Diagnosis of Autosomal Dominant Polycystic Kidney Disease

- Age > 18 years old

- Estimated Glomerular Filtration Rate (eGFR) > 30 mL/min/1.73m2

- Treatment with at least one anti-hypertensive
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to provide Informed Consent

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/03/2023
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
Westmead Institute for Medical Research - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Westmead Institute for Medical Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05401409
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
G K Rangan
Address 0 0
Westmead Hospital, Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries