Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000074796p
Ethics application status
Submitted, not yet approved
Date submitted
13/12/2021
Date registered
21/01/2022
Date last updated
21/01/2022
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of high dose quercetin – a potential treatment for asthma
Scientific title
Pharmacokinetics of high dose quercetin – a potential treatment for adults with asthma
Secondary ID [1] 306011 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 324683 0
Condition category
Condition code
Respiratory 322127 322127 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Oral quercetin 1000mg twice a day for 6 weeks
Arm 2: Oral quercetin 2000mg twice a day for 6 weeks

Adherence to assigned dose of quercetin supplementation will be assessed by returned capsule count at week 2 and 6.
Intervention code [1] 322439 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329893 0
Steady state plasma quercetin level at 6 weeks
Timepoint [1] 329893 0
After 6 weeks of high dose quercetin supplementation
Secondary outcome [1] 404183 0
Full blood count
Timepoint [1] 404183 0
Baseline and after 6 weeks of high dose quercetin supplementation
Secondary outcome [2] 404184 0
Renal function (assessed by eGFR from blood test)
Timepoint [2] 404184 0
Baseline and after 6 weeks of high dose quercetin supplementation
Secondary outcome [3] 404185 0
Liver function (assessed by liver function test from blood test)
Timepoint [3] 404185 0
Baseline and after 6 weeks of high dose quercetin supplementation
Secondary outcome [4] 404186 0
Serum C-reactive protein
Timepoint [4] 404186 0
Baseline and after 6 weeks of high dose quercetin supplementation
Secondary outcome [5] 404187 0
Adherence to supplementation (assessed by returned capsule count at end of study)
Timepoint [5] 404187 0
After 6 weeks of high dose quercetin supplementation
Secondary outcome [6] 404188 0
Adverse events (e.g. gastro-intestinal discomfort, nausea, anorexia, headache, etc) reported
and documented by participants on diary cards
Timepoint [6] 404188 0
After 6 weeks of high dose quercetin supplementation

Eligibility
Key inclusion criteria
1. Age greater than or equal to 18 years
2. Able to provide informed consent
3. Body mass index 18.0 – 35.0 kg/m2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participants with chronic kidney disease with eGFR < 30
2. Participants with evidence of active or suspected cancer and participants having undergone cancer treatment including resection, radiation therapy or chemotherapy within the last 2 years (participants with basal cell carcinoma and squamous cell carcinoma are allowed)
3. Participation in a separate clinical or device trial within 4 weeks of screening
4. Participants currently taking cyclosporine, pravastatin, fexofenadine, and/or midazolam
5. Pregnant or lactating women
6. Allergy to quercetin

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2022
Actual
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
22/07/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 24400 0
New Zealand
State/province [1] 24400 0

Funding & Sponsors
Funding source category [1] 310354 0
Other
Name [1] 310354 0
Counties Manukau Health Tupu Fund
Country [1] 310354 0
New Zealand
Funding source category [2] 310377 0
Hospital
Name [2] 310377 0
Middlemore Hospital
Country [2] 310377 0
New Zealand
Primary sponsor type
Individual
Name
Leon Huang
Address
Middlemore Hospital
100 Hospital Road,
Otahuhu
Auckland, 2025
Country
New Zealand
Secondary sponsor category [1] 311518 0
None
Name [1] 311518 0
Address [1] 311518 0
Country [1] 311518 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310010 0
Health and Disability Ethics Committees
Ethics committee address [1] 310010 0
Ministry of Health
133Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 310010 0
New Zealand
Date submitted for ethics approval [1] 310010 0
19/11/2021
Approval date [1] 310010 0
Ethics approval number [1] 310010 0

Summary
Brief summary
Quercetin is a naturally occurring antioxidant with antiviral and anti-inflammatory activity. It has been shown to reduce many inflammatory pathways that are present in asthma and inhibits the activity of common respiratory viruses that can cause flare-ups in patients with asthma. The benefits of quercetin in clinical trials have been inconsistent and this is likely due to the small amount of quercetin that is absorbed into the bloodstream and the relatively low doses of quercetin used in most clinical trials. Much larger doses of quercetin are likely to be required to attain beneficial clinical effects. We plan to undertake a feasibility study to evaluate whether higher doses of quercetin can attain adequate blood concentrations, and to assess the safety of these high doses. This information will inform the development of a randomised controlled trial of quercetin for the treatment of asthma.

This study is a single centre, dose-ranging, open-label study of high dose oral quercetin in adults randomised to receive either 2000 mg daily, or 4000 mg daily in two divided doses. Primary outcome measured is the plasma quercetin level after 6 weeks of high dose supplementation. Secondary outcomes includes change in full blood count, renal function, liver function, c-reactive protein, adherence and adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116174 0
Dr Leon Huang
Address 116174 0
Department of Respiratory Medicine
Middlemore Hospital
100 Hospital Road,
Otahuhu
Auckland, 2025
Country 116174 0
New Zealand
Phone 116174 0
+64 021 215 9029
Fax 116174 0
Email 116174 0
leonyu-an.huang@middlemore.co.nz
Contact person for public queries
Name 116175 0
Dr Leon Huang
Address 116175 0
Department of Respiratory Medicine
Middlemore Hospital
100 Hospital Road,
Otahuhu
Auckland, 2025
Country 116175 0
New Zealand
Phone 116175 0
+64 09 276 0000
Fax 116175 0
Email 116175 0
leonyu-an.huang@middlemore.co.nz
Contact person for scientific queries
Name 116176 0
Dr Leon Huang
Address 116176 0
Department of Respiratory Medicine
Middlemore Hospital
100 Hospital Road,
Otahuhu
Auckland, 2025
Country 116176 0
New Zealand
Phone 116176 0
+64 09 276 0000
Fax 116176 0
Email 116176 0
leonyu-an.huang@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14415Study protocol  leonyu-an.huang@middlemore.co.nz
14417Informed consent form  leonyu-an.huang@middlemore.co.nz
14418Ethical approvalPending leonyu-an.huang@middlemore.co.nz
14419Statistical analysis plan  leonyu-an.huang@middlemore.co.nz



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.