Home » Trials » SLCTR/2019/031
Dietary behavior of patients with urolithiasis and antiurolithic effects of selected local fruits
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SLCTR Registration Number
SLCTR/2019/031
Date of Registration
The date of last modification
Sep 17, 2019
Scientific Title of Trial
Dietary behavior of patients with urolithiasis and antiurolithic effects of selected local fruits
Public Title of Trial
Anti-urolithic effect of selected local fruits on serum and urinary biomarkers in patients with urolithiasis: A Randomized Controlled Trial
Disease or Health Condition(s) Studied
Urolithiasis
Scientific Acronym
None
Public Acronym
None
Brief title
Effect of selected local fruits on biochemical parameters in urolithiasis
Universal Trial Number
UTN : U1111-1236-9898
Any other number(s) assigned to the trial and issuing authority
Ref: 06.09.2017: 3.1: ERC Ruhuna
What is the research question being addressed?
What is the effect of selected local fruits on urinary and serum parameters (citrate, tartaric acid, uric acid, oxalate, sodium, potassium, creatinine, phosphorus, and magnesium) of patients with urolithiasis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Eight different local fruit types [Thambili ( Cocos nucifera), Hen-Kekiri ( Cucumis melovar conomon), Delum ( Punica granatum), Annasi ( Ananas comosus), Pipincha/Thiyambara ( Cucumis sativus Pipingna), Komadu/ Peni-Komadu ( Colocynthis citrullus),Kaju Puhulum ( Anacardium occidentals), Katuanodha ( Annona muricata)] will be used for the study which are believed to have diuretic and/or antiurolithic effect according to Sri Lankan traditional Aryurwedic Medicine.
Study participants will be recruited from Urology Surgical Unit and General Surgical Unit, Teaching Hospital, Karapitiya.
Block randomization will be used to allocate patients for the eight fruit groups (applicable for group1 and 3). Block size will be taken as 8. Computer generated random number table will be used for the sequence generation. Allocation is not concealed and blinding is not used for the study. Group 2 and 4 are used for comparison.
Group 1: Patients with confirmed urolithiasis will be advised to drink one type of fruit juice (500 mL) daily for 14 days.
Group 2: Patients with confirmed urolithiasis will be advised to drink a 500 mL of drinking water (other than usual intake) daily for 14 days.
Group 3: Voluntary participants without urolithiasis (negative imaging studies) will be advised to drink 500 mL of the same type of fruit juice daily for 14 days.
Group 4: Voluntary participants without urolithiasis (negative imaging studies) will be advised to drink 500 mL of drinking water (other than usual intake) daily for 14 days.
Intervention: 500 mL of fruit juice once daily for 14 days. Fruit juices will be prepared without added sugar or salt using ripened fruits (100g wet weight of the fruit for 250 mL of drinking water).
Control: 500 mL of drinking water once daily for 14 days.
Standard treatment for nephrolithiasis is the surgical management. The intervention/control treatment is administered while the patient is on standard treatment.
Blinding is not used.
Regular nutritional intake by the study subject will be estimated by a food frequency questionnaire validated for Sri Lankans.
Inclusion criteria
For Groups 1 and 2 • Age 20 to 70 years • Male or Female • Diagnosed with urolithiasis at the Urological and General Surgical Units (defined and confirmed by the imaging studies)
For Groups 3 and 4 • Age 20 to 70 years • Male or Female • Patients without urolithiasis (negative imaging studies)
Exclusion criteria
• Patients with major illnesses such as renal failure, acute infections including acute urinary tract infections (eg: payelonephritis), carcinoma, diabetes mellitus
• Unstable patients (Patients who are unstable mentally (patients with psychiatric disorders and dementia) or physically (bedridden patients)
Primary outcome(s)
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[ At the baseline and at 15th day after the commencement of the intervention ] |
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[ At the baseline and at 15th day after the commencement of the intervention ] |
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[ At the baseline and at 15th day after the commencement of the intervention ] |
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[ At the baseline and at 15th day after the commencement of the intervention ] |
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5.
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[ At the baseline and at 15th day after the commencement of the intervention ] |
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[ At the baseline and at 15th day after the commencement of the intervention ] |
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7.
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[ At the baseline and at 15th day after the commencement of the intervention ] |
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8.
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[ At the baseline and at 15th day after the commencement of the intervention ] |
Secondary outcome(s)
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None |
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Target number/sample size
180 (100 in control group and 80 intervention group)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-11-01
Anticipated end date
2021-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Research Grant, Faculty of Medicine, University of Ruhuna
Regulatory approvals
Status
Approved
Date of Approval
2017-09-06
Approval number
06.09.2017: 3.1
Details of Ethics Review Committee
| Name: | Ethical Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | Ethical Review Committee, Faculty of Medicine, University of Ruhuna, PO Box 70, Galle, Sri Lanka. |
| Telephone: | 0912234801/803 Ext: 161 |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. C. M. Wickramatilake
Senior Lecturer
Dept. of Biochemistry
Faculty of Medicine
University of Ruhuna
Galle.
091 2234801
0777909663
0912222314
chandimadhu@live.com
Contact Person for Public Queries
Dr. Satish Goonesinghe
Consultant Urological Surgeon
Teaching Hospital Karapitiya
Galle
0912232176
0777751165
satkugo@gmail.com
Primary study sponsor/organization
Faculty of Medicine, University of Ruhuna
Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka
041-2222681, 041-2222682 041-2227001
0912222314
deanmedruh@gmail.com
http://www.medi.ruh.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results being reported, will be shared after de-identification (text, tables, figures and appendices). The study protocol will also be shared. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, including for individual participant data meta analysis. Proposals should be directed to (inset email). To gain access, data requestors will need to sign a data access agreement
Study protocol available
Yes
Protocol version and date
Version 2
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
