Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT05389995
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05389995
Study Brief:
Protocol Section:
NCT05389995