Clinical trial

Evaluation of Multiple Alkalinizing Agents on Urinary Stone Risk Parameters in Stone and Non-stone Formers on a Metabolically Controlled Diet

ID

Name

STU-2020-0613

Description

The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

Trial arms

Trial start

2024-12-01

Estimated PCD

2025-12-01

Trial end

2026-07-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Potassium citrate

Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily.

Arms:

Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate

Sodium bicarbonate

650mg tabs. Take 3 tabs twice daily.

Arms:

Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate

Litholyte

One packet is taken with 170ml of water. Two packets daily.

Arms:

Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate

Crystal Lite

The classic lemonade contains 21.7mEq/liter of alkali Therefore, patients will take 2 litres daily to have the 40mEq of alkali daily needed.

Arms:

Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate

Potassium Bicarbonate

20 mEq tablets, one tablet twice daily

Arms:

Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate

Size

15

Primary endpoint

24 hour urine volume

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hour urine volume

Change from baseline (Day 4) to end of study (day 12)

24 hour urine creatinine

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hour urine creatinine

Change from baseline (Day 4) to end of study (day 12)

24 hour urine calcium

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hour urine calcium

Change from baseline (Day 4) to end of study (day 12)

24 hour urine potassium

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hour urine potassium

Change from baseline (Day 4) to end of study (day 12)

24 hour urine sodium

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hours urine sodium

Change from baseline (Day 4) to end of study (day 12)

24 hours urine citrate

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hours urine citrate

Change from baseline (Day 4) to end of study (day 12)

24 hours urine uric acid

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hours urine uric acid

Change from baseline (Day 4) to end of study (day 12)

24 hours urine oxalate

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hours urine oxalate

Change from baseline (Day 4) to end of study (day 12)

24 hours urine magnesium

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hours urine magnesium

Change from baseline (Day 4) to end of study (day 12)

24 hours urine ammonia

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hours urine ammonia

Change from baseline (Day 4) to end of study (day 12)

24 Hour Urine pH

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 Hour Urine pH

Change from baseline (Day 4) to end of study (day 12)

24 hour urine phosphorus

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hour urine phosphorus

Change from baseline (Day 4) to end of study (day 12)

24 hour urine sulfate

Change from baseline (Day 4) to initial start on treatment (Day 5)

24 hour urine sulfate

Change from baseline (Day 4) to end of study (day 12)

Eligibility criteria

Inclusion Criteria: * Adults aged 18 and older. * with or without a history of stone disease. Exclusion Criteria: * They are unable to take any of the medications due to health reasons. * Participants are pregnant or nursing. * Participants are unable to adhere to the metabolic diet. * Participants had a prior adverse event from one or more of the medications.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}

Updated at

2024-03-01

1 organization

3 products

1 indication

Organization

University of Texas Southwestern Medical Center

Product

Potassium citrate

Indication

Product

Sodium bicarbonate

Product

Potassium Bicarbonate