Treatment for Calcium Phosphate Kidney Stone Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01754779|
Recruitment Status : Recruiting
First Posted : December 21, 2012
Last Update Posted : October 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Calcium Phosphate Kidney Stones||Drug: Placebo Dietary Supplement: Citric Acid Dietary Supplement: Potassium Citrate Drug: Indapamide||Phase 2|
We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pharmacological Therapy for Calcium Phosphate Urolithiasis|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Placebo Comparator: Calcium Phosphate stone formers without hypercalciuria
Each subject will undergo 3 phases, the order of which will be randomized by a simple randomization scheme. The 3 phases will be Placebo, Citric Acid, and Potassium Citrate. Each phase will be 1 week in duration, during which subjects will take assigned study medications. A 1-week washout period is imposed between phases.
Matching placebo for both aims.Dietary Supplement: Citric Acid Dietary Supplement: Potassium Citrate
Placebo Comparator: Calcium Phosphate stone formers with hypercalciuria
Each hypercalciuric CaP stone former will undergo 3 phases, the order of which will be randomized by a simple randomization scheme.
Matching placebo for both aims.Dietary Supplement: Citric Acid Dietary Supplement: Potassium Citrate Drug: Indapamide
- Urinary calcium phosphate saturation [ Time Frame: 2 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754779
|Contact: Ann Heard-Sakhaee, RNfirstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390-8885|
|Contact: Naim M Maalouf, MD|
|Principal Investigator:||Naim M Maalouf, MD||UT Southwestern Medical Center|