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CTRI Number  CTRI/2017/07/009143 [Registered on: 27/07/2017] Trial Registered Retrospectively
Last Modified On: 19/07/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Structural Changes In Crystals In Urine Of Calcium Oxalate Stone Patients With Changes In Diet. 
Scientific Title of Study   Effect Of Dietary Modifications On The Morphology Of Calcium Oxalate Crystals And Corresponding Changes In The Optical Density Of Urine Of Patients With Calcium Oxalate Stones In The Urinary Tracts. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Sathish Kumar 
Designation  Additional Professor Urology 
Affiliation  Government Medical College, Thiruvananthapuram, 
Address  Department of Urology Government Medical College Thiruvananthapuram, Kerala 695011
Government Medical College Thiruvananthapuram Kerala 695011
Thiruvananthapuram
KERALA
695011
India 
Phone  9446455385  
Fax    
Email  drgsatheeshkurup@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jim Joe 
Designation  Assistant Professor Biochemistry 
Affiliation  Government Medical College, Kottayam 
Address  Department of Biochemistry Government Medical College Kottayam, Kerala 686008
Government Medical College, Kottayam Kerala 686008
Kottayam
KERALA
686008
India 
Phone  9544156643  
Fax    
Email  drjimjoe@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jim Joe 
Designation  Assistant Professor Biochemistry 
Affiliation  Government Medical College, Kottayam 
Address  Department of Biochemistry Government Medical College Kottayam, Kerala 686008
Government Medical College Kottayam Kerala 686008
Kottayam
KERALA
686008
India 
Phone  9544156643  
Fax    
Email  drjimjoe@gmail.com  
 
Source of Monetary or Material Support  
Kerala State Council For Science Technology and Environment (KSCSTE) Sasthra Bhavan,Pattom P.O. Thiruvananthapuram. Pin-695004 Kerala,India Tel:0471-2548200,2548205,2548209 FAX:0471-2540085,2533095,2543556 e-mail: mailto@kscste.org www.kscste.kerala.gov.in 
 
Primary Sponsor  
Name  Kerala State Council For Science Technology and Environment 
Address  KSCSTE Sasthra Bhavan, Pattom P.O., Thiruvananthapuram, Kerala, 695004 Tel: 0471-2543701/02/03/04/05 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Government MeDical College Thiruvananthapuram  Government Medical College, Thiruvananthapuram Kerala 695001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrJim Joe  Government Medical College, Kottayam  Department of Urology
Kottayam
KERALA 
9566435441

drjimjoe@gmail.com 
DrJim Joe  Government Medical College, Thiruvananthapuram  UROLOGY RESEARCH Department of Urology Super Specialty Block Government Medical College Thiruvananthapuram Kerala 695011
Thiruvananthapuram
KERALA 
9544156643

drjimjoe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
HUMAN ETHICS COMMITTEE, Medical College Thiruvananthapuram  Approved 
INSTITUTIONAL REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with calcium oxalate stones in the urinary tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High Calcium diet followed by High Oxalate diet.  Dose: 200 ML. Milk + 2 calcium tablets + bland diet for breakfast followed four hours later by high oxalate diet for lunch. Frequency : Once in a week Duration : 1 week  
Comparator Agent  Low Calcium diet followed by High Oxalate diet.  Bland diet plus high citrate juice for breakfast followed by high oxalate diet for lunch. Frequency : Once in a week Duration : 1 week  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who have been diagnosed with calcium oxalate urinary stones 
 
ExclusionCriteria 
Details  1.Patients who do not have calcium based urinary stones( such as uric acid, cystine, struvite)
2. Patients with obstructive uropathy , chronic urosepsis,/ positive urine culture , Renal failure, Renal tubular acidosis, Primary hyper oxaluria, Medullary sponge kidney
3. Less than 19 years
4. Patients with abnormalities of the urinary tracts
5. Serious diseases
6. Pregnancy
7. Active cancer
8. Recurrent Urinary tract infection
9. Gross hematuria
10.Inability to give informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To determine the in vitro morphological changes in calcium oxalate crystals in native urine of patients and corresponding variation in the optical density of urine as a function of in vitro super saturation of these urine samples following dietary modifications  Four hours after diet intake 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the in vitro morphological changes in calcium oxalate crystals in native urine of patients and corresponding variation in the optical density of urine as a function of in vitro super saturation of these urine samples following dietary modifications after a period of two months  Two months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/05/2016 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Patients diagnosed with calcium oxalate stones in the urinary tract are taken up for the study .Pilot studies of the trial were conducted at Govt. Medical College, Kottayam. The final part of the study is being conducted at Govt. Medical College, Thiruvananthapuram.
Each patient is advised to come for testing after partaking bland diet for one day. Each patient is given the following two sets of diet in a gap of 3 days in a week .Following the first diet the patient remains for three days on bland diet and reports for the second  tests.
1) High calcium diet followed 4 hrs later by high oxalate diet .Urine samples are collected after two hours of each diet.  Changes in the morphology ( size and number) of urine crystals and corresponding changes in the optical density of are studied
2) Low calcium diet followed 4 hrs later by low oxalate  diet .Urine samples are collected two hours and four hours of each diet. Changes in the morphology (size and number) of urine crystals and corresponding changes in the optical density are studied.
 
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