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Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria Clinical research trials and Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria. Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria clinical trial. Participants oftentimes recieve the most expert healthcare available for their Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria
Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria
For Condition: Hypercalciuria,Kidney Calculi
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),University of Texas
Synopsis: OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
Details: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. Patients receive potassium phosphate or potassium citrate tablets twice a day for 3 years.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Absorptive hypercalciuria Intestinal hyperabsorption of calcium, i.e.: Exaggerated calciuric response to oral calcium load OR Fractional calcium-47 absorption greater than 0.61 Calciuria greater than 200 mg/day on random and calcium-restricted diet Normal or high fasting urinary calcium Normal serum calcium Normal serum parathyroid hormone No primary hyperparathyroidism At least 1 calcium oxalate stone within the past 3 years No struvite or carbonate apatite stones No noncalcareous stones No numerous stones making precise quantitation difficult No renal tubular acidosis --Prior/Concurrent Therapy-- No concurrent drug therapy for nephrolithiasis --Patient Characteristics-- Creatinine clearance at least 0.7 mL/min per kilogram No hyperkalemia No hyperphosphatemia No urinary tract infection Other: No predisposition to hyperkalemia, including concurrent use of the following drugs: Potassium-sparing diuretics Angiotensin-converting enzyme inhibitors Nonsteroidal anti-inflammatory drugs No active peptic ulcer disease No chronic diarrhea
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
CharlesC. Pak, Study Chair, University of Texas
Additional Information:
Study ID Numbers: 199/11703; UTSMC-039510400
Study Start Date: April 1995
Record last reviewed: June 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004284
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1. Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria
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Phase III Randomized, Double-Blind Study of Potassium Phosphate vs Potassium Citrate for Absorptive Hypercalciuria
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