Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

Tracking Information
First Submitted Date ICMJE	March 16, 2010
First Posted Date ICMJE	March 17, 2010
Last Update Posted Date	December 24, 2013
Study Start Date ICMJE	November 2009
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 16, 2010)	Change in supersaturation of calcium oxalate / phosphate [ Time Frame: 1 week ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01088555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers
Official Title ICMJE	Pilot Study : Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers
Brief Summary	Sodium thiosulfate may be useful to prevent recurrence of calcium-containing kidney stones. It will be studied in people with high amounts of urine calcium.
Detailed Description	The investigators study is designed as a pilot study to study the effect of STS on urine chemistries in stone formers and normal controls. It is expected to continue for a duration of 1 year and will have two groups: 20 normal controls, who are healthy subjects without known kidney disease or nephrolithiasis, and 20 subjects with documented recurrent nephrolithiasis and hypercalciuria. Patients will be recruited from Dr Goldfgarb's stone clinic at VA Hospital and controls would be voluntary participants from NYU School of Medicine. Subjects who are pregnant or nursing, taking alcohol or drugs, have known CKD or are unable to give consent would be excluded from the study. Any diuretics or citrate containing drugs would be held for a period of 2 weeks during the study period to achieve washout of the effects of those drugs on urine chemistries. Oral STS 10mmol (10ml of 25% STS) BID will be administered to both groups for 7 days; four 24 hour urine collections, 2 prior and 2 at the end of the study, would be done with all participants. A diet diary would be maintained by subjects concomitantly during the study periods. The investigators then plan to compare the two groups in terms of urine chemistries to detect any changes in these parameters with thiosulfate administration. Based on prior animal experiments and human studies with STS the investigators anticipate that it would have a favorable effect on the supersaturation of Ca oxalate/phosphate and therefore its long term use would be helpful in preventing nephrolithiasis.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Kidney Stones
Intervention ICMJE	Drug: Sodium thiosulfate; Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days
Study Arms	Active Comparator: Control group Healthy subjects with no history of kidney stones, heart liver or kidney disease, not pregnant /lactating. Intervention: Drug: Sodium thiosulfate; Active Comparator: Stone formers History of calcium containing kidney stones, hypercalciuria on previous urine tests, no heart /liver / kidney disease, not pregnant/lactating Intervention: Drug: Sodium thiosulfate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 16, 2010)	10
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2011
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Control arm: no longer recruiting Hypercalciuria arm: Age 18-80 years old; history of calcium-containing kidney stones; no history of liver, heart or kidney disease (other than kidney stones); Non-pregnant, non-lactating; Able to stop diuretics for a period of 1 week Exclusion Criteria: Not able to sign consent; Not satisfying any of the above criteria
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01088555
Other Study ID Numbers ICMJE	01098
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	David S. Goldfarb, M.D., VA New York Harbor Healthcare System
Study Sponsor ICMJE	VA New York Harbor Healthcare System
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: David S Goldfarb, MD New York Harbor VA Medical Center
PRS Account	VA New York Harbor Healthcare System
Verification Date	December 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP