Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers
Recruitment status was Recruiting
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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 |
- Change in supersaturation of calcium oxalate / phosphate [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated 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 |
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| United States, New York | |
| VA New York Harbor Healthcare System | Recruiting |
| New York, New York, United States, 10010 | |
| Contact: David Goldfarb, M.D 212-686-7500 ext 3877 david.goldfarb@va.gov | |
| Contact: Frank Modersitzki, MPH 212-686-7500 ext 6379 frank.modersitzki@nyumc.org | |
| Principal Investigator: David Goldfarb, M.D | |
| Principal Investigator: | David S Goldfarb, MD | New York Harbor VA Medical Center |
More Information
No publications provided
| Responsible Party: | David Goldfarb, VANYHHS |
| ClinicalTrials.gov Identifier: | NCT01088555 History of Changes |
| Other Study ID Numbers: | 01098 |
| Study First Received: | March 16, 2010 |
| Last Updated: | February 14, 2011 |
| 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 Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Chelating Agents Antidotes |
ClinicalTrials.gov processed this record on May 21, 2013