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

NCT02711670 | Completed

• 1 other identifier: 01417
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stones

Keywords

nephrolithiasis; calcium stones; kidney stones; hypercalciuria; thiazide

Outcome Measures

Primary Outcomes (1)

• Change in excretion and supersaturation of urine calcium oxalate / phosphate

  1 week

Study Arms (1)

thiazide

EXPERIMENTAL

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

Drug: chlorthalidone; Drug: Hydrochlorothiazide

Interventions

chlorthalidone DRUG

thiazide

Hydrochlorothiazide DRUG

thiazide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA New York Harbor Healthcare System: lead

Study Sites (1)

VA New York Harbor Healthcare System

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis; Hypercalciuria

Interventions

Chlorthalidone; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Thiazides

Study Officials

• David Goldfarb, MD

  New York Harbor VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: March 17, 2016
• Study Start: February 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

US (1)