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Kidney Stone | Potassium Citrate Supplementation vs. Dietary Counseling

Kidney Stone research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Kidney Stone

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Potassium Citrate Supplementation20 mEq taken twice daily

Other:Dietary EducationDietary 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Dietary EducationParticipants in this treatment arm will undergo dietary counseling for the prevention of kidney stone formation.

Potassium Citrate and Dietary EducationParticipants in this treatment arm will undergo potassium citrate supplementation and dietary counseling for the prevention of kidney stone formation.

Study Status

Withdrawn

Start Date: November 2013

Completed Date: August 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Change in 24-hour urine parameters

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Davis J Viprakasit, MD

Lead Sponsor: University of North Carolina, Chapel Hill

Collaborator: Vanderbilt University

More information:https://clinicaltrials.gov/show/NCT01980004

Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.

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