Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

PHASE4CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

August 4, 2022

Primary Completion Date

October 17, 2025

Study Completion Date

October 17, 2025

Conditions
Kidney StonesNephrolithiasis
Interventions
BEHAVIORAL

Empiric Therapy: Diet

Diet: High water intake - at least 2.5 liters daily Reduce sugar-sweetened cola intake to ≤3 cans per week. Reduce salt intake to \<2000mg sodium daily Reduce red meat intake to two 4-ounce portions per week Normal calcium intake: 3 servings of dairy products (or their equivalents) per day Increase vegetable and fruit intake to ≥5 servings per day Reduce oxalate intake to \<100 mg/day

DRUG

Empiric Therapy: Drug

Drug(s): indapamide 1.25mg and potassium citrate 15mEq daily.

BEHAVIORAL

Selective Therapy: Diet

"Diet:~Volume \<2.5L Increase fluid intake to ≥ 2.5L/d, based on specific urine volume~Calcium \>250mg male, \>200mg female Reduce red meat intake to two 4-oz portions/wk; reduce sodium intake to\<2000mg/d, avoid vitamin D + calcium supplements~Oxalate \>40mg Reduce dietary oxalate intake to \<100 mg/d; increase fiber intake to 25-35 g/d~Citrate \<450mg male, \<550mg female Reduce red meat intake to two 4-oz portions/wk; increase fruit and vegetable intake to ≥5 svgs/d~pH\<5.8 Reduce red meat intake to two 4-oz portions/wk; increase fruit and vegetable intake to ≥5 svgs/d~Uric acid \>800mg male, \>750mg female Reduce red meat intake to two 4- oz portions/wk; increase fruit and vegetable intake to ≥5 svgs/d~Sodium \>150mmol Reduce sodium intake to \<2000mg/d~Sulfate \> 80mEq or urine urea nitrogen \>14g Reduce red meat intake to three 3-4 oz portions/wk; increase fruit and vegetable intake to ≥5 svgs/d"

DRUG

Selective Therapy: Drug

"Drug(s):~For calcium \>250mg male, \>200mg female: indapamide 1.25mg and potassium chloride 20mEq. At 1 month if persistent, then increase to indapamide 2.5mg and potassium chloride 20mEq. For citrate \<450mg male, \<550mg female: potassium citrate 15mEq BID. At 1 month if persistent, then increase to potassium citrate 30mEq BID. For pH\<5.8: potassium citrate 15mEq BID. At month if persistent, then increase to potassium citrate 30mEq BID. For uric acid \>800mg male, \>750mg female: allopurinol 300mg.~If both elevated calcium and low pH: indapamide 1.25mg and potassium citrate 15mEq BID If both elevated calcium and low citrate: indapamide 1.25mg and potassium citrate 15mEq BID"

Trial Locations (1)

37232

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER