Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

NCT ID: NCT01088555

Last Updated: 2013-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-12-31

Brief 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.

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.

Conditions

Kidney Stones

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Healthy subjects with no history of kidney stones, heart liver or kidney disease, not pregnant /lactating.

Group Type: ACTIVE_COMPARATOR

Sodium thiosulfate

Intervention Type: DRUG

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

Stone formers

History of calcium containing kidney stones, hypercalciuria on previous urine tests, no heart /liver / kidney disease, not pregnant/lactating

Group Type: ACTIVE_COMPARATOR

Sodium thiosulfate

Intervention Type: DRUG

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

Interventions

Sodium thiosulfate

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA New York Harbor Healthcare System

FED

Sponsor Role: lead

Responsible Party

David S. Goldfarb, M.D.

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David S Goldfarb, MD

Role: PRINCIPAL_INVESTIGATOR

New York Harbor VA Medical Center

Locations

VA New York Harbor Healthcare System

New York, New York, United States

Countries

United States

Other Identifiers

01098

Identifier Type: -

Identifier Source: org_study_id