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

Primary Purpose

Kidney Stones

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chlorthalidone
Hydrochlorothiazide
Sponsored by
VA New York Harbor Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Stones focused on measuring nephrolithiasis, calcium stones, kidney stones, hypercalciuria, thiazide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA New York Harbor Healthcare System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thiazide

Arm Description

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

Outcomes

Primary Outcome Measures

Change in excretion and supersaturation of urine calcium oxalate / phosphate

Secondary Outcome Measures

Full Information

First Posted
February 4, 2015
Last Updated
April 25, 2023
Sponsor
VA New York Harbor Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT02711670
Brief Title
Night Time Use of Thiazide Diuretics for Improved Reduction in Stone Risk in Stone Formers With Elevated Urine Calcium
Official Title
Night-time Use of Thiazide Diuretics for Improved Reduction in Stone Risk in Stone Formers With Elevated Urine Calcium
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA New York Harbor Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
nephrolithiasis, calcium stones, kidney stones, hypercalciuria, thiazide

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thiazide
Arm Type
Experimental
Arm Description
Stone formers History of calcium containing kidney stones, hypercalciuria on previous urine tests, no kidney disease, not pregnant/lactating
Intervention Type
Drug
Intervention Name(s)
chlorthalidone
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Primary Outcome Measure Information:
Title
Change in excretion and supersaturation of urine calcium oxalate / phosphate
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Goldfarb, MD
Organizational Affiliation
New York Harbor VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA New York Harbor Healthcare System
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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