Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-31 @ 6:45 AM
Study NCT ID:
NCT05389995
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2022-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potassium Citrate and Crystal Light Lemonade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019357', 'term': 'Potassium Citrate'}], 'ancestors': [{'id': 'D019343', 'term': 'Citric Acid'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2022-05-17', 'studyFirstSubmitQcDate': '2022-05-21', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urine citrate levels', 'timeFrame': 'Day 7 of week 1', 'description': '24 hour urine collection'}, {'measure': 'urine citrate levels', 'timeFrame': 'Day 7 of week 3', 'description': '24 hour urine collection'}, {'measure': 'urine citrate levels', 'timeFrame': 'Day 7 of week 5', 'description': '24 hour urine collection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Stone']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women between age 18-80 years\n2. Willing to follow experimental protocol\n3. Willing to complete 24-hour urine collections (three total)\n4. Willing to sign the informed consent form\n5. Completed Litholink Collection with blood work with results\n\n a. hypocitraturia OR aciduria i. Hypocitraturics must meet definition of \\< 450 mg/day for men \\< 550 mg/day for women.\n\n b. Low urine pH must be less than 5.6 c. potassium, BUN, creatinine, eGFR and hemoglobin A1c within normal limits\n\nExclusion Criteria:\n\n1. Patients with severe hypocitraturia \\< 200 mg/day (men or women)\n2. 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\n3. Patients with distal renal tubular acidosis or medication induced RTA (e.g. carbonic anhydrase inhibitor, topiramate)\n4. Members of vulnerable patient populations\n5. Allergies to ingredients in crystal light\n6. Patients lacking decisional capacity'}, 'identificationModule': {'nctId': 'NCT05389995', 'briefTitle': 'Potassium Citrate and Crystal Light Lemonade', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors', 'orgStudyIdInfo': {'id': 'STU00216084'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Potassium citrate', 'interventionNames': ['Drug: Potassium citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crystal light', 'interventionNames': ['Drug: Crystal light']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crystal light + potassium citrate', 'interventionNames': ['Drug: Potassium citrate + crystal light']}], 'interventions': [{'name': 'Potassium citrate', 'type': 'DRUG', 'description': '7 days potassium citrate followed by 24 hour urine collection', 'armGroupLabels': ['Potassium citrate']}, {'name': 'Crystal light', 'type': 'DRUG', 'description': '7 days crystal light followed by 24 hour urine collection', 'armGroupLabels': ['Crystal light']}, {'name': 'Potassium citrate + crystal light', 'type': 'DRUG', 'description': '7 days potassium citrate + crystal light followed by 24 hour urine collection', 'armGroupLabels': ['Crystal light + potassium citrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alyssa McDonald', 'role': 'CONTACT', 'email': 'alyssa.mcdonald@northwestern.edu'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Alyssa McDonald', 'role': 'CONTACT', 'email': 'alyssa.mcdonald@northwestern.edu', 'phone': '3126958146'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Endourology/Stone Division', 'investigatorFullName': 'Amy Krambeck', 'investigatorAffiliation': 'Northwestern University'}}}}