An interventional study of chlorthalidone and Hydrochlorothiazide in Kidney Stones, sponsored by VA New York Harbor Healthcare System. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by VA New York Harbor Healthcare System · Not applicable, Interventional, and Prevention
Thiazide diuretics will be more effective in lowering urine calcium excretion if taken at night as compared to the daytime. It will therefore be more effective in reducing kidney stone recurrence in nephrolithiasis patients with elevated urine calcium who are known to have increased risk of kidney stones at night time.
The study will be divided into three phases for every single patient, investigators will study 15-20 stone formers who have previously documented elevated urine calcium excretion, with a plan to measure their urine chemistries at baseline (if they currently use thiazide diuretics, they will come off of their respective thiazide for a 7-day washout period). Investigators will ask them to collect urine samples in two 12-hour intervals: on awakening, the 1st sample starts to before supper; 2nd sample begins after dinner and extends overnight with fasting after dinner, These measurements will be used as controls. Then patients will be started back on diuretics (25mg of chlorthalidone for the primary study; pending the results this may be repeated with 25mg of hydrochlorothiazide as a second substudy) which they will take in the daytime; after a 6-day acclimation period, two 12-hour urine samples will be collected as in the washout period. For the third study period, the patients will then begin taking the thiazide after dinner. After a 6-day acclimation period, the third set of urine collections will be done.
605 studies on the registry are indexed under Kidney Calculi; 164 are open to participants now.
This study's enrollment of 10 is below the median of 90 across 464 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →VA New York Harbor Healthcare System is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Stone formers History of calcium containing kidney stones, hypercalciuria on previous urine tests, no kidney disease, not pregnant/lactating
Drug: chlorthalidone · Drug: Hydrochlorothiazide
Change in excretion and supersaturation of urine calcium oxalate / phosphate
Time frame: 1 week
Ran from Feb 2014 to primary completion in Jun 2017, 40 months.
Of 231 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 40 months is above that.
Counting every sponsor, half of 248 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Chlorthalidone · Hydrochlorothiazide
VA New York Harbor Healthcare System