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Potassium Citrate Supplementation vs. Dietary Counseling

Primary Purpose

Kidney Stone

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Potassium Citrate Supplementation
Dietary Education
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Carolina Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dietary Education

Potassium Citrate and Dietary Education

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in 24-hour urine parameters

Secondary Outcome Measures

Full Information

First Posted
November 1, 2013
Last Updated
October 7, 2015
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01980004
Brief Title
Potassium Citrate Supplementation vs. Dietary Counseling
Official Title
Does Potassium Citrate Supplementation Reduce Stone Recurrence in Calcium Phosphate Stone Formers With Risk Factors?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
closure due to failure to recruit any patients that met study criteria
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Education
Arm Type
Experimental
Arm Description
Participants in this treatment arm will undergo dietary counseling for the prevention of kidney stone formation.
Arm Title
Potassium Citrate and Dietary Education
Arm Type
Experimental
Arm Description
Participants in this treatment arm will undergo potassium citrate supplementation and dietary counseling for the prevention of kidney stone formation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Potassium Citrate Supplementation
Intervention Description
20 mEq taken twice daily
Intervention Type
Other
Intervention Name(s)
Dietary Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 24-hour urine parameters
Time Frame
4-6 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years old, being seen at UNC Chapel Hill or Vanderbilt Urology Clinics Documented stone analysis with ≥ 50% calcium phosphate (hydroxyapatite and/or brushite) composition 24 hour urine citrate (≤ 500) on initial evaluation of at least one 24-hour urine study 24 hour urine pH ≥ 6.0 on initial evaluation of at least one 24-hour urine study Exclusion Criteria: Documented stone analysis with any calcium carbonate or magnesium ammonium phosphate composition Systemic cause for stone disease (primary hyperparathyroidism, complete distal renal tubular acidosis, systemic acidosis, active urinary tract infection) 24 hour urine calcium/kg (> 4) or 24 hour urine calcium/Cr (>140) on initial evaluation of at least one 24-hour urine study Concurrent medication therapy (potassium citrate, sodium citrate, sodium bicarbonate, diuretic, angiotensin-converting enzyme inhibitor, angiotensin II receptor antagonist, topiramate, acetazolamide) Renal insufficiency (GFR ≤ 60) Elevated serum potassium level (≥ 4.5) or hyperkalemia Low serum bicarbonate level (< 24) High serum calcium level (>10) Pregnancy Inability to obtain informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davis J Viprakasit, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Carolina Memorial Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22498635
Citation
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.
Results Reference
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PubMed Identifier
15253733
Citation
Parks JH, Worcester EM, Coe FL, Evan AP, Lingeman JE. Clinical implications of abundant calcium phosphate in routinely analyzed kidney stones. Kidney Int. 2004 Aug;66(2):777-85. doi: 10.1111/j.1523-1755.2004.00803.x.
Results Reference
background
PubMed Identifier
12771710
Citation
Mandel N, Mandel I, Fryjoff K, Rejniak T, Mandel G. Conversion of calcium oxalate to calcium phosphate with recurrent stone episodes. J Urol. 2003 Jun;169(6):2026-9. doi: 10.1097/01.ju.0000065592.55499.4e.
Results Reference
background
PubMed Identifier
1561497
Citation
Preminger GM. Renal calculi: pathogenesis, diagnosis, and medical therapy. Semin Nephrol. 1992 Mar;12(2):200-16.
Results Reference
background
PubMed Identifier
15086911
Citation
Chow K, Dixon J, Gilpin S, Kavanagh JP, Rao PN. Citrate inhibits growth of residual fragments in an in vitro model of calcium oxalate renal stones. Kidney Int. 2004 May;65(5):1724-30. doi: 10.1111/j.1523-1755.2004.00566.x.
Results Reference
background
PubMed Identifier
10608522
Citation
Pattaras JG, Moore RG. Citrate in the management of urolithiasis. J Endourol. 1999 Nov;13(9):687-92. doi: 10.1089/end.1999.13.687.
Results Reference
background
PubMed Identifier
19152932
Citation
Robinson MR, Leitao VA, Haleblian GE, Scales CD Jr, Chandrashekar A, Pierre SA, Preminger GM. Impact of long-term potassium citrate therapy on urinary profiles and recurrent stone formation. J Urol. 2009 Mar;181(3):1145-50. doi: 10.1016/j.juro.2008.11.014. Epub 2009 Jan 18.
Results Reference
background
PubMed Identifier
17919696
Citation
Penniston KL, Steele TH, Nakada SY. Lemonade therapy increases urinary citrate and urine volumes in patients with recurrent calcium oxalate stone formation. Urology. 2007 Nov;70(5):856-60. doi: 10.1016/j.urology.2007.06.1115. Epub 2007 Oct 24.
Results Reference
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Potassium Citrate Supplementation vs. Dietary Counseling

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