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Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

Primary Purpose

Kidney Stones

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium thiosulfate
Sponsored by
VA New York Harbor Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring nephrolithiasis, calcium stones, kidney stones, hypercalciuria, sodium thiosulfate, Calcium containing kidney stones

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA New York Harbor Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

Stone formers

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in supersaturation of calcium oxalate / phosphate

Secondary Outcome Measures

Full Information

First Posted
March 16, 2010
Last Updated
December 23, 2013
Sponsor
VA New York Harbor Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT01088555
Brief Title
Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers
Official Title
Pilot Study : Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA New York Harbor Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
nephrolithiasis, calcium stones, kidney stones, hypercalciuria, sodium thiosulfate, Calcium containing kidney stones

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Healthy subjects with no history of kidney stones, heart liver or kidney disease, not pregnant /lactating.
Arm Title
Stone formers
Arm Type
Active Comparator
Arm Description
History of calcium containing kidney stones, hypercalciuria on previous urine tests, no heart /liver / kidney disease, not pregnant/lactating
Intervention Type
Drug
Intervention Name(s)
Sodium thiosulfate
Intervention Description
Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days
Primary Outcome Measure Information:
Title
Change in supersaturation of calcium oxalate / phosphate
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Goldfarb, MD
Organizational Affiliation
New York Harbor VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA New York Harbor Healthcare System
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

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