Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2012-07-31
2023-02-16
Brief Summary
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Detailed Description
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The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo.
The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo, then Citric Acid, then Potassium Citrate
Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)
Placebo
3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid
3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate
2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Placebo, then Potassium Citrate, then Citric Acid
Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)
Placebo
3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid
3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate
2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Potassium Citrate, then Placebo, then Citric Acid
Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)
Placebo
3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid
3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate
2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Potassium Citrate, then Citric Acid, then Placebo
Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)
Placebo
3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid
3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate
2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Citric Acid, then Potassium Citrate, then Placebo
Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)
Placebo
3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid
3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate
2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Citric Acid, then Placebo, then Potassium Citrate
Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)
Placebo
3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid
3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate
2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Interventions
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Placebo
3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid
3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate
2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Eligibility Criteria
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Inclusion Criteria
* Hypocitraturic CaP stone formers
* urine citrate \<320mg/d
* elevated pH as 24-hr urine pH above 6.40
* \>21 years
Aim 2
* Hypercalciuric CaP stone formers
* 24hr urine calcium \>250mg/d in women and \>300mg/d in men prior to indapamide use
* high pH as \>6.40 in the absence of urinary tract infection
* \>21 years
21 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Naim Maalouf
Associate Professor of Medicine
Principal Investigators
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Naim M Maalouf, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Doizi S, Poindexter JR, Pearle MS, Blanco F, Moe OW, Sakhaee K, Maalouf NM. Impact of Potassium Citrate vs Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers. J Urol. 2018 Dec;200(6):1278-1284. doi: 10.1016/j.juro.2018.07.039. Epub 2018 Jul 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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032012-058
Identifier Type: -
Identifier Source: org_study_id
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