Study Stopped
closure due to failure to recruit any patients that met study criteria
Potassium Citrate Supplementation vs. Dietary Counseling
Does Potassium Citrate Supplementation Reduce Stone Recurrence in Calcium Phosphate Stone Formers With Risk Factors?
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 12, 2015
September 1, 2015
1.7 years
November 1, 2013
October 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in 24-hour urine parameters
4-6 weeks from baseline
Study Arms (2)
Dietary Education
EXPERIMENTALParticipants in this treatment arm will undergo dietary counseling for the prevention of kidney stone formation.
Potassium Citrate and Dietary Education
EXPERIMENTALParticipants in this treatment arm will undergo potassium citrate supplementation and dietary counseling for the prevention of kidney stone formation.
Interventions
20 mEq taken twice daily
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.
Eligibility Criteria
You may qualify if:
- 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
- hour urine citrate (≤ 500) on initial evaluation of at least one 24-hour urine study
- hour urine pH ≥ 6.0 on initial evaluation of at least one 24-hour urine study
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- Vanderbilt Universitycollaborator
Study Sites (1)
North Carolina Memorial Hospital
Chapel Hill, North Carolina, 27599, United States
Related Publications (8)
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.
PMID: 22498635BACKGROUNDParks 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.
PMID: 15253733BACKGROUNDMandel 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.
PMID: 12771710BACKGROUNDPreminger GM. Renal calculi: pathogenesis, diagnosis, and medical therapy. Semin Nephrol. 1992 Mar;12(2):200-16.
PMID: 1561497BACKGROUNDChow 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.
PMID: 15086911BACKGROUNDPattaras JG, Moore RG. Citrate in the management of urolithiasis. J Endourol. 1999 Nov;13(9):687-92. doi: 10.1089/end.1999.13.687.
PMID: 10608522BACKGROUNDRobinson 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.
PMID: 19152932BACKGROUNDPenniston 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.
PMID: 17919696BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Davis J Viprakasit, MD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2013
First Posted
November 8, 2013
Study Start
November 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 12, 2015
Record last verified: 2015-09