Health TrialsbyHealthPanel

Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet

ConditionKidney Stone
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 and older.

with or without a history of stone disease.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Potassium citrate

    Drug

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

  • Sodium bicarbonate

    Drug

    650mg tabs. Take 3 tabs twice daily.

  • Litholyte

    Dietary supplement

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

  • Crystal Lite

    Dietary supplement

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

  • Potassium Bicarbonate

    Drug

    20 mEq tablets, one tablet twice daily

Treatment groups

15 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Metabolic dietPlacebo comparator 5 interventions
Group B: Potassium citrateActive comparator 5 interventions
Group C: Sodium BicarbonateActive comparator 5 interventions
Group D: Litholyte armActive comparator 5 interventions
Group E: Crystal LiteActive comparator 5 interventions
Group F: Potassium BicarbonateActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

24 hour urine volume

Total urine volume

Time frame
Change from baseline (Day 4) to initial start on treatment (Day 5)
2

24 hour urine volume

Total urine volume

Time frame
Change from baseline (Day 4) to end of study (day 12)
3

24 hour urine creatinine

Urine creatinine

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

24 hour urine creatinine

Urine creatinine

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

Secondary outcomes

1

# of patient who adherence to 100% Medication

Patient's adherence to medication for duration of study.

Time frame
At the end of study approximately 10 weeks after start of study.
2

Total out of pocket cost

Calculate and compare treatment costs for the different interventions (in American dollars).

Time frame
At the end of study approximately 10 weeks after start of study.
3

Patient's Satisfaction Survey

Patient satisfaction survey, adapted from the Treatment Satisfaction Questionnaire for Medication-14. Patients are queried on their satisfaction, with 9 questions for each medication.

Time frame
At the end of study approximately 10 weeks after start of study.
4

Patient's GI Distress

Patient's GI distress symptom scale measures patients GI distress. There are 18 questions with descriptive answers ranging from "none", "mild", "moderate", "quite a lot" and "unbearable". There are no numerical scores, rather just descriptive scores. "None" means no GI distress, "unbearable" means that you are in a lot of distress from your GI symptoms.

Time frame
At the end of study approximately 10 weeks after start of study.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: