Alpha Lipoic Acid for Cystinuria
(ALA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study evaluates how daily alpha lipoic acid supplementation affects cystine kidney stone recurrence. Half of the subjects will receive 1200 mg alpha lipoic acid orally daily for three years, while the other half will receive a placebo. The funding source for this clinical trial is FDA OOPD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are currently taking alpha-lipoic acid, you would need to stop, as the trial excludes those who have taken it within the last year.
Is alpha-lipoic acid safe for humans?
How does the drug alpha-lipoic acid differ from other treatments for cystinuria?
Alpha-lipoic acid is unique because it acts as a powerful antioxidant, which may help protect the kidneys from damage. This is different from other treatments for cystinuria that primarily focus on reducing cystine levels in the urine. Its potential to minimize oxidative stress could offer a novel approach to managing kidney-related complications in cystinuria.678910
What evidence supports the effectiveness of the drug alpha-lipoic acid for treating cystinuria?
Alpha-lipoic acid has shown potential in reducing oxidative stress and improving kidney function in conditions like obstructive nephropathy and experimental renal lithiasis, which involve similar mechanisms to cystinuria. Its antioxidant properties may help protect the kidneys and prevent stone formation.110111213
Who Is on the Research Team?
Thomas Chi, M.D.
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people with cystinuria who've had kidney stones made of cystine. They must have documented evidence of the condition, be willing to consent, and not be pregnant or planning pregnancy during the study. It's not for those with uncontrolled diabetes, current alpha-lipoic acid use, non-English speakers, prisoners, or anyone seriously ill.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 1200 mg alpha lipoic acid or placebo daily for three years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alpha lipoic acid
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Thomas Chi, MD
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator