Night-time Use of Thiazide Diuretics for Improved Reduction in Stone Risk in Stone Formers With Elevated Urine Calcium

Night Time Use of Thiazide Diuretics for Improved Reduction in Stone Risk in Stone Formers With Elevated Urine Calcium

Sponsors

Lead sponsor: VA New York Harbor Healthcare System

Source VA New York Harbor Healthcare System
Brief Summary

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.

Detailed Description

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.

Overall Status Unknown status
Start Date February 2014
Completion Date June 2017
Primary Completion Date June 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in excretion and supersaturation of urine calcium oxalate / phosphate 1 week
Enrollment 10
Condition
Intervention

Intervention type: Drug

Intervention name: chlorthalidone

Arm group label: thiazide

Intervention type: Drug

Intervention name: Hydrochlorothiazide

Arm group label: thiazide

Eligibility

Criteria:

Inclusion Criteria:

- Patients with recurrent calcium kidney stones (at least 2 episodes) and either a higher urine calcium excretion (urine Ca >200 mg/d or > 4 mg/kg body weight) or,

- In patients who currently take a thiazide diuretic, a history of elevated urine calcium prior to medication use;

- Also capable of signing consent and doing 24-hour urine collections repeatedly.

Exclusion Criteria:

- Patients with primary hyperparathyroidism, renal tubular acidosis, chronic kidney disease (serum creatinine > 1.5 mg/dl), inflammatory bowel disease, gout,

- Patients taking thiazides with a history of hypertension,

- Patients with baseline systolic blood pressure less than 110mmHg

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
David Goldfarb, MD Principal Investigator New York Harbor VA Medical Center
Overall Contact

Last name: David Goildfarb, MD

Phone: 212-686-7500

Phone ext: 6379

Email: [email protected]

Location
facility status contact VA New York Harbor Healthcare System David Goldfarb, MD 212-686-7500 3877 [email protected]
Location Countries

United States

Verification Date

March 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: VA New York Harbor Healthcare System

Investigator full name: David S. Goldfarb, M.D.

Investigator title: PI

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: thiazide

Arm group type: Experimental

Description: Stone formers History of calcium containing kidney stones, hypercalciuria on previous urine tests, no kidney disease, not pregnant/lactating

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov