Potassium Citrate Supplementation vs. Dietary Counseling

October 7, 2015 updated by: University of North Carolina, Chapel Hill

Does Potassium Citrate Supplementation Reduce Stone Recurrence in Calcium Phosphate Stone Formers With Risk Factors?

The purpose of this study is to compare the role of potassium citrate supplementation with dietary education versus dietary education alone in the reduction of stone risks and events in patients with predominantly calcium phosphate kidney stones.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The prevalence of kidney stone disease in the United States is increasing. Concurrently, an increase in calcium phosphate stone composition is also being observed. Recurrence of kidney stone disease has been reported as high as 50% at five years. Citrate supplementation is widely considered as one of the primary medical cornerstones to decrease kidney stone recurrence. Urinary citrate is a potent inhibitor of calcium stone formation by binding ionic urinary calcium as well as direct inhibition of calcium oxalate formation. Additionally, increased citrate, an alkali, raises urine pH which alters the solubility of certain stone types including uric acid and cystine stones. Potassium citrate supplementation is the primary proven approach to increasing urinary citrate and is a well-established preventive option in stone disease. However, medication treatment can cause epigastric discomfort, frequent large bowel movements and add to the patient's prescription financial burden. Dietary education including lemonade therapy provides natural dietary sources of citrate and may be an alternative to pharmacologic therapy without the associated gastrointestinal symptoms or costs.

The utility of citrate supplementation has not been previously evaluated prospectively in the calcium phosphate stone former. Calcium phosphate stone formation occurs in a more alkaline urine environment. It has been postulated that citrate supplementation could promote calcium phosphate stone occurrence due to its ability to raise urine pH despite the inhibitory effects of increasing urinary citrate. However, this finding has not been observed in limited retrospective studies. The purpose of this investigation is to prospectively evaluate the benefit of citrate supplementation either through potassium citrate treatment with dietary education vs. dietary education alone to reduce stone recurrence in calcium phosphate stone formers with risk factors.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • North Carolina Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients ≥ 18 years old, being seen at UNC Chapel Hill or Vanderbilt Urology Clinics
  2. Documented stone analysis with ≥ 50% calcium phosphate (hydroxyapatite and/or brushite) composition
  3. 24 hour urine citrate (≤ 500) on initial evaluation of at least one 24-hour urine study
  4. 24 hour urine pH ≥ 6.0 on initial evaluation of at least one 24-hour urine study

Exclusion Criteria:

  1. Documented stone analysis with any calcium carbonate or magnesium ammonium phosphate composition
  2. Systemic cause for stone disease (primary hyperparathyroidism, complete distal renal tubular acidosis, systemic acidosis, active urinary tract infection)
  3. 24 hour urine calcium/kg (> 4) or 24 hour urine calcium/Cr (>140) on initial evaluation of at least one 24-hour urine study
  4. Concurrent medication therapy (potassium citrate, sodium citrate, sodium bicarbonate, diuretic, angiotensin-converting enzyme inhibitor, angiotensin II receptor antagonist, topiramate, acetazolamide)
  5. Renal insufficiency (GFR ≤ 60)
  6. Elevated serum potassium level (≥ 4.5) or hyperkalemia
  7. Low serum bicarbonate level (< 24)
  8. High serum calcium level (>10)
  9. Pregnancy
  10. Inability to obtain informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary Education
Participants in this treatment arm will undergo dietary counseling for the prevention of kidney stone formation.
Other: Dietary Education
Dietary counseling will include both a verbal discussion in the clinic regarding increased fluid intake, a moderate calcium rich diet and lemonade therapy as well as receiving a written handout on these topics.
Experimental: Potassium Citrate and Dietary Education
Participants in this treatment arm will undergo potassium citrate supplementation and dietary counseling for the prevention of kidney stone formation.
Other: Dietary Education
Dietary counseling will include both a verbal discussion in the clinic regarding increased fluid intake, a moderate calcium rich diet and lemonade therapy as well as receiving a written handout on these topics.
Dietary supplement: Potassium Citrate Supplementation
20 mEq taken twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 24-hour urine parameters
Time Frame: 4-6 weeks from baseline
4-6 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Vanderbilt University

Investigators

  • Principal Investigator: Davis J Viprakasit, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-3010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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