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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

Study 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.Check my eligibility
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.See study design
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

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

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
1,048 Previous Clinical Trials
1,053,796 Total Patients Enrolled
4 Trials studying Kidney Stones
637 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the inclusion criteria for this study restricted to those aged 85 and under?

"This medical experiment is searching for participants aged 18 or above, and no older than 90 years old."

Answered by AI

What medical issues is Crystal Lite typically utilized to address?

"Crystal Lite is primarily prescribed to treat nephrolithiasis, a disease caused by calcium oxalate. It has also been used to combat barbiturate addiction, helicobacter infections, and acute diarrhea."

Answered by AI

Who is eligible to participate in this clinical experiment?

"The enrolment criteria for this clinical trial necessitates that applicants possess a history of kidney stones and are between 18 to 90 years old. Fifteen individuals will be accepted into the study."

Answered by AI

What is the desired outcome of this experiment?

"This medical trial will primarily assess the change in 24-hour urine uric acid from baseline to the end of study (Day 12). Secondary objectives involve collecting data from a Patient Satisfaction Survey, measuring patient adherence to medication throughout the duration of the study, and assessing overall satisfaction with an 18 question Patients Satisfaction Questionnaire Short Form. Scores range between 18-90, where higher scores indicate greater levels of contentment."

Answered by AI

How many participants are actively enrolled in this clinical trial?

"Affirmative, according to the information on clinicaltrials.gov this medical experiment is actively seeking participants despite being uploaded as early as March 16th 2021 and its most recent update occurring June 30th 2022. 15 persons from a single site must be enrolled in order for the trial to commence."

Answered by AI

Are there still vacancies for this clinical experiment?

"Current information hosted on clinicaltrials.gov indicates that this trial is presently recruiting participants. It was initially announced on March 16th 2021 and the most recent update occured June 30th 2022."

Answered by AI

Are there any other scientific experiments that have utilized Crystal Lite?

"Currently, 27 clinical trials for Crystal Lite are ongoing with 2 in Phase 3. Decatur, Georgia is home to several of these studies and a total of 42 sites are running tests on this medication globally."

Answered by AI
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~10 spots leftby Dec 2025