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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - Beetroot juice
Treatment: Other - 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


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

Treatment: Other: Nitrate-depleted beetroot juice
70mls beetroot juice (nitrate-depleted) given daily for 4 weeks
Intervention code [1] 0 0
Treatment: Other
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05401409