Clinical trial

Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors

Name
STU00216084
Description
To define the effect of crystal light, potassium citrate, or both on urinary stone risk factors in patients with a history of stone and hypocitraturia/low pH
Trial arms
Trial start
2022-08-01
Estimated PCD
2024-07-01
Trial end
2025-03-31
Status
Recruiting
Treatment
Potassium citrate
7 days potassium citrate followed by 24 hour urine collection
Arms:
Potassium citrate
Crystal light
7 days crystal light followed by 24 hour urine collection
Arms:
Crystal light
Potassium citrate + crystal light
7 days potassium citrate + crystal light followed by 24 hour urine collection
Arms:
Crystal light + potassium citrate
Size
10
Primary endpoint
urine citrate levels
Day 7 of week 1
urine citrate levels
Day 7 of week 3
urine citrate levels
Day 7 of week 5
Eligibility criteria
Inclusion Criteria: 1. Men and women between age 18-80 years 2. Willing to follow experimental protocol 3. Willing to complete 24-hour urine collections (three total) 4. Willing to sign the informed consent form 5. Completed Litholink Collection with blood work with results a. hypocitraturia OR aciduria i. Hypocitraturics must meet definition of \< 450 mg/day for men \< 550 mg/day for women. b. Low urine pH must be less than 5.6 c. potassium, BUN, creatinine, eGFR and hemoglobin A1c within normal limits Exclusion Criteria: 1. Patients with severe hypocitraturia \< 200 mg/day (men or women) 2. Patients with hyperkalemia, uncontrolled diabetes, chronic kidney disease, adrenal insufficiency, delayed gastric emptying (or drug induced delayed gastric emptying), peptic ulcer disease, or active UTI 3. Patients with distal renal tubular acidosis or medication induced RTA (e.g. carbonic anhydrase inhibitor, topiramate) 4. Members of vulnerable patient populations 5. Allergies to ingredients in crystal light 6. Patients lacking decisional capacity
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2024-06-07

1 organization

2 products

1 indication

Indication
Kidney Stone