Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

Summary

The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.

Conditions

• Kidney Stones
• Nephrolithiasis

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

Sponsors & Collaborators

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Ryan Hsi, MD · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-04

Primary Completion

2025-10-17

Completion

2025-10-17

FDA Drug

Yes

Countries

• United States

Study Locations