We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01088555
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : December 24, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Kidney Stones Drug: Sodium thiosulfate

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study : Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers
Study Start Date : November 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Control group
Healthy subjects with no history of kidney stones, heart liver or kidney disease, not pregnant /lactating.
Drug: Sodium thiosulfate
Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days
Active Comparator: Stone formers
History of calcium containing kidney stones, hypercalciuria on previous urine tests, no heart /liver / kidney disease, not pregnant/lactating
Drug: Sodium thiosulfate
Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days

Outcome Measures

Primary Outcome Measures :
  1. Change in supersaturation of calcium oxalate / phosphate [ Time Frame: 1 week ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088555

United States, New York
VA New York Harbor Healthcare System
New York, New York, United States, 10010
Sponsors and Collaborators
VA New York Harbor Healthcare System
Principal Investigator: David S Goldfarb, MD New York Harbor VA Medical Center
More Information

Responsible Party: David S. Goldfarb, M.D., PI, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier: NCT01088555     History of Changes
Other Study ID Numbers: 01098
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by David S. Goldfarb, M.D., VA New York Harbor Healthcare System:
calcium stones
kidney stones
sodium thiosulfate
Calcium containing kidney stones

Additional relevant MeSH terms:
Kidney Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi
Sodium thiosulfate
Protective Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents