Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

David S. Goldfarb, M.D., VA New York Harbor Healthcare System

ClinicalTrials.gov Identifier:

NCT01088555

First received: March 16, 2010

Last updated: December 23, 2013

Last verified: December 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 16, 2010

Last Updated Date

December 23, 2013

Start Date ^ICMJE

November 2009

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in supersaturation of calcium oxalate / phosphate [ Time Frame: 1 week ] [ Designated as safety issue: No ]

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 Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

December 2011

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

Gender

Both

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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