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

March 16, 2010
December 23, 2013
November 2009
December 2011   (final data collection date for primary outcome measure)
Change in supersaturation of calcium oxalate / phosphate [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01088555 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers
Pilot Study : Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Stones
Drug: Sodium thiosulfate
Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01088555
01098
No
David S. Goldfarb, M.D., VA New York Harbor Healthcare System
VA New York Harbor Healthcare System
Not Provided
Principal Investigator: David S Goldfarb, MD New York Harbor VA Medical Center
VA New York Harbor Healthcare System
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP