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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01088555
Other study ID # 01098
Secondary ID
Status Completed
Phase N/A
First received March 16, 2010
Last updated December 23, 2013
Start date November 2009
Est. completion date December 2011

Study information

Verified date December 2013
Source VA New York Harbor Healthcare System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sodium thiosulfate
Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days

Locations

Country Name City State
United States VA New York Harbor Healthcare System New York New York

Sponsors (1)

Lead Sponsor Collaborator
VA New York Harbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in supersaturation of calcium oxalate / phosphate 1 week
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