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
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
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
[email protected]
Contact person for public queries
Name 116175 0
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
[email protected]
Contact person for scientific queries
Name 116176 0
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
[email protected]

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  [email protected]
14417Informed consent form  [email protected]
14418Ethical approvalPending [email protected]
14419Statistical analysis plan  [email protected]



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.