| CTRI Number |
CTRI/2018/01/011371 [Registered on: 16/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of blood and 24 hour urine parameters for primary as well as recurrent stone formers. |
|
Scientific Title of Study
|
Comparative study of detailed metabolic work up evaluation in primary and recurrent renal stone formers. Is it warranted in primary stone formers and how effective will it be in the prevention of recurrent episodes? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paul Vincent D |
| Designation |
Consultant Urologist |
| Affiliation |
MEENAKSHI MISSION HOSPITAL |
| Address |
Department of Urology
Meenakshi Mission Hospital and Research centre
LAKE AREA
MELUR ROAD
MADURAI
Madurai
TAMIL NADU
625107
India |
| Phone |
4522543000 |
| Fax |
91452254300 |
| Email |
pauldevincent@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paul Vincent D |
| Designation |
Consultant Urologist |
| Affiliation |
MEENAKSHI MISSION HOSPITAL |
| Address |
Department of Urology
Meenakshi Mission Hospital and Research centre
LAKE AREA
MELUR ROAD
MADURAI
Madurai
TAMIL NADU
625107
India |
| Phone |
4522543000 |
| Fax |
91452254300 |
| Email |
pauldevincent@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paul Vincent D |
| Designation |
Consultant Urologist |
| Affiliation |
MEENAKSHI MISSION HOSPITAL |
| Address |
Department of Urology
Meenakshi Mission Hospital and Research centre
LAKE AREA
MELUR ROAD
MADURAI
Madurai
TAMIL NADU
625107
India |
| Phone |
4522543000 |
| Fax |
91452254300 |
| Email |
pauldevincent@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Mission Hospital & Research Centre
Lake Area, Melur Road
Madurai - 625107.
Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Department of Urology Meenakshi Mission Hospital Research Centre |
| Address |
Meenakshi Mission Hospital and Research Centre
Lake area
Melur Road
Madurai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Meenakshi Mission Hospital Research Centre |
Meenakshi Mission Hospital and Research Centre
Lake area
Melur Road
Madurai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Paul Vincent |
Meenakshi Mission Hospital & Research Centre |
Department of Urology, 4th Floor, Meenakshi Mission Hospital & Research Centre,Lake area, Melur Road, Madurai - 625107.
Tamil Nadu, India
Madurai
TAMIL NADU |
9626733363
pauldevincent@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MMHRC-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stone formers - primary / recurrent stone formers, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All primary as well as recurrent stone formers aged 18-60 years who are willing to undergo detailed metabolic evaluation |
|
| ExclusionCriteria |
| Details |
1. Chldren
2. Pregnant subjects
3. Infection stones
4. Chronic kidney disease (Serum creatinine >1.8 mg/dL)
5. Known metabolic disorder patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood investigations - serum creatinine, calcium, sodium, uric acid, phosphorus and total proteins.
24 hour urine sample for pH, calcium, sodium, chloride, uric acid, oxalate and citrate. |
At 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in the 24 hour urine metabolic parameters between primary and recurrent stone formers |
One point |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The incidence of renal stone is quite high. Dietary choices are important causative factors. The chance of recurrence after one episode of stone formation is as high as 50% in a 5 year follow up period. The guidelines suggest detailed metabolic work up evaluation for finding the causation of stone formation in recurrent and high risk stone formers. Recent studies have shown similar recurrence rate in primary stone formers as well. There is a shift in the evaluation of primary stone formers. Previously, no evaluation was suggested. But now considering the risk of recurrence some form of evaluation is advocated. This study will focus on the detailed metabolic evaluation reports in primary as well as recurrent stone formers and draw a comparison between them. This is to identify that whether detailed metabolic evaluation is helpful in primary stone formers. |