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
  Purpose

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 Intervention
Kidney Stones
Drug: Sodium thiosulfate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study : Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

Resource links provided by NLM:


Further study details as provided by VA New York Harbor Healthcare System:

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

Enrollment: 10
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088555

Locations
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
Investigators
Principal Investigator: David S Goldfarb, MD New York Harbor VA Medical Center
  More Information

No publications provided

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
Study First Received: March 16, 2010
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by VA New York Harbor Healthcare System:
nephrolithiasis
calcium stones
kidney stones
hypercalciuria
sodium thiosulfate
Calcium containing kidney stones

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

ClinicalTrials.gov processed this record on September 16, 2014