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Alkalinizing Agent

Alkalinizing Agents for Kidney Stones

Phase < 1
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (day 4) to end of study (day 12)
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial will compare three different types of medicines to see which is best at preventing kidney stones.

Who is the study for?
This trial is for adults aged 18 or older, with or without a history of kidney stones. It's not suitable for those who can't take the medications due to health reasons, pregnant or nursing individuals, anyone unable to follow a strict metabolic diet, or if they've had bad reactions to these meds before.
What is being tested?
The study compares different urinary alkalinizing agents like Potassium Bicarbonate, Litholyte, Crystal Lite, Sodium bicarbonate and prescription Potassium citrate. Their effectiveness in changing urine properties to reduce kidney stone risk while on a controlled diet is being tested.
What are the potential side effects?
Possible side effects from the alkalinizing agents may include gastrointestinal discomfort such as bloating and stomach pain, electrolyte imbalances which could affect muscle function and heart rhythm, and potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (day 4) to end of study (day 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (day 4) to end of study (day 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
24 Hour Urine pH
24 hour urine calcium
24 hour urine creatinine
+11 more
Secondary study objectives
# of patient who adherence to 100% Medication
Patient's GI Distress
Patient's Satisfaction Survey
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: Crystal LiteActive Control5 Interventions
Group II: Potassium BicarbonateActive Control5 Interventions
Group III: Potassium citrateActive Control5 Interventions
Group IV: Sodium BicarbonateActive Control5 Interventions
Group V: Litholyte armActive Control5 Interventions
Group VI: Metabolic dietPlacebo Group5 Interventions
Controlled metabolic diet arm.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,086 Previous Clinical Trials
1,058,647 Total Patients Enrolled
5 Trials studying Kidney Stones
777 Patients Enrolled for Kidney Stones

Media Library

Crystal Lite (Alkalinizing Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04651088 — Phase < 1
Kidney Stones Research Study Groups: Crystal Lite, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate, Metabolic diet, Litholyte arm
Kidney Stones Clinical Trial 2023: Crystal Lite Highlights & Side Effects. Trial Name: NCT04651088 — Phase < 1
Crystal Lite (Alkalinizing Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04651088 — Phase < 1
~10 spots leftby Dec 2025
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