Pilot Study : Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

Sponsors

Lead sponsor: VA New York Harbor Healthcare System

Source VA New York Harbor Healthcare System
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.

Overall Status Completed
Start Date November 2009
Completion Date December 2011
Primary Completion Date December 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in supersaturation of calcium oxalate / phosphate 1 week
Enrollment 10
Condition
Intervention

Intervention type: Drug

Intervention name: Sodium thiosulfate

Description: Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
David S Goldfarb, MD Principal Investigator New York Harbor VA Medical Center
Location
facility VA New York Harbor Healthcare System
Location Countries

United States

Verification Date

December 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: VA New York Harbor Healthcare System

Investigator full name: David S. Goldfarb, M.D.

Investigator title: PI

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control group

Arm group type: Active Comparator

Description: Healthy subjects with no history of kidney stones, heart liver or kidney disease, not pregnant /lactating.

Arm group label: Stone formers

Arm group type: Active Comparator

Description: History of calcium containing kidney stones, hypercalciuria on previous urine tests, no heart /liver / kidney disease, not pregnant/lactating

Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov