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Completed

NCT Number: NCT01088555

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium thiosulfate

Drug

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

Primary outcomes

  1. Change in supersaturation of calcium oxalate / phosphate

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

VA New York Harbor Healthcare System

Fed

Registry information

Official study title

Pilot Study : Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 17, 2010
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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