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Trial registered on ANZCTR


Registration number
ACTRN12610000791033
Ethics application status
Approved
Date submitted
20/09/2010
Date registered
24/09/2010
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-term effects of lemonade therapy on hypocitraturic
nephrolithiasis and stone recurrence
Scientific title
Long-term effects of lemonade therapy on hypocitraturic
nephrolithiasis and stone recurrence
Secondary ID [1] 252746 0
none
Universal Trial Number (UTN)
U1111-1117-1574
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypocitraturic
nephrolithiasis
258220 0
Condition category
Condition code
Alternative and Complementary Medicine 258397 258397 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Lemonade therapy consisted of 120 ml concentrated lemon juice (5.9 gram citric acid) mixed with 2 liters water consumed throughout each day and last for 8 years.
The patients were asked to comsume enough fluid to urinate at least 2 L daily.
Intervention code [1] 257236 0
Treatment: Other
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259271 0
mean change in urinary citrate level.Baseline study included 2 24-hour urine samples, followed by 2-hour fasting urine sample collected on the morning of the following day along with a venous blood sample. Urine was kept refrigerated during collection and analyzed for calcium, sodium, potassium, magnesium, uric acid, citrate, oxalate, and creatinine. Urine volume was measured for both 24-hour urine collections, and urinary pH was determined immediately post-voiding urine samples. The patients were studied at least 8 years.
Timepoint [1] 259271 0
Patients were followed in an outpatient setting yearly, at which time abdominal x-rays and noncontrast abdominal/pelvic computerized tomography, a 2 24- hour urine sample and venous blood were obtained for the same tests as before treatment.
Secondary outcome [1] 265679 0
Stone burden.Patients were followed in an outpatient setting yearly, at which time abdominal x-rays and noncontrast abdominal/pelvic computerized tomography, a 2 24- hour urine sample and venous blood were obtained for the same tests as before treatment.
Timepoint [1] 265679 0
Patients were followed in an outpatient setting yearly, at which time abdominal x-rays and noncontrast abdominal/pelvic computerized tomography, a 2 24- hour urine sample and venous blood were obtained for the same tests as before treatment.

Eligibility
Key inclusion criteria
All patients with a history of hypocitraturic nephrolithiasis ( defined as less than 320 mg citrate in a 24-hour urine collection ) who were aged 45 to 55 years were eligible.
Minimum age
45 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with solitary kidney, renal insufficiency, infectious stones, or active stone disease with pain, hematuria, or obstruction and those taking thiazide-type diuretics were excluded. Pregnancy and ongoing medical treatment for stone disease were also reasons for exclusion.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2924 0
Taiwan, Province Of China
State/province [1] 2924 0
600-00
Country [2] 2925 0
Taiwan, Province Of China
State/province [2] 2925 0

Funding & Sponsors
Funding source category [1] 257680 0
Self funded/Unfunded
Name [1] 257680 0
Chung-Jing Wang
Address [1] 257680 0
60058 No. 565 2nd Ta-Ya Rd. Chia-Yi city,Taiwan,ROC
St Martin De Porres Hospital
Country [1] 257680 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Chung-Jing Wang
Address
60058 No. 565 2nd Ta-Ya Rd. Chia-Yi city,Taiwan,ROC
St Martin De Porres Hospital
Country
Taiwan, Province Of China
Secondary sponsor category [1] 256897 0
None
Name [1] 256897 0
Address [1] 256897 0
Country [1] 256897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259712 0
Institutional Review Board,St Martin De Porres Hospital
Ethics committee address [1] 259712 0
60058 No. 565 2nd Ta-Ya Rd. Chia-Yi city,Taiwan,ROC
St Martin De Porres Hospital
Ethics committee country [1] 259712 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 259712 0
14/11/1999
Approval date [1] 259712 0
12/12/1999
Ethics approval number [1] 259712 0
STM-00-08

Summary
Brief summary
Citrus fruits and juices are a known natural source of dietary citrate. Of all the citrus juices, lemon juice appears
to have the highest concentration of citrate. Therefore, lemonade therapy has been proposed as a potential treatment forpatients with hypocitraturia. We prosspectively evaluated the impact of long-term lemonade therapy on urinary metabolic parameters and stone formation in patients with hypocitraturic nephrolithiasis.
Trial website
Trial related presentations / publications
not yet
Public notes

Contacts
Principal investigator
Name 31666 0
A/Prof Chung-Jing Wang
Address 31666 0
60058 No. 565 2nd Ta-Ya Rd. Chia-Yi city,Taiwan,ROC
St Martin De Porres Hospital
Country 31666 0
Taiwan, Province Of China
Phone 31666 0
886-5-2756000-1013
Fax 31666 0
886-5-2788535
Email 31666 0
jing@stm.org.tw
Contact person for public queries
Name 14913 0
A/Prof Chung-Jing Wang
Address 14913 0
60058 No. 565 2nd Ta-Ya Rd. Chia-Yi city,Taiwan,ROC
St Martin De Porres Hospital
Country 14913 0
Taiwan, Province Of China
Phone 14913 0
886-5-2756000ext1013
Fax 14913 0
886-5-2788535
Email 14913 0
jing@stm.org.tw
Contact person for scientific queries
Name 5841 0
A/Prof Chung-Jing Wang
Address 5841 0
60058 No. 565 2nd Ta-Ya Rd. Chia-Yi city,Taiwan,ROC
St Martin De Porres Hospital
Country 5841 0
Taiwan, Province Of China
Phone 5841 0
886-5-2756000ext1013
Fax 5841 0
886-5-2788535
Email 5841 0
jing@stm.org.tw

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary