Lipoic Acid Supplement for Cystine Stone

• Status: Active, not recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Chi, MD; University of California, San Francisco
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Thioctic Acid

Criteria

Inclusion Criteria:

• Documented cystinuria on prior 24-hour urine collection and/or stone analysis; history of previous cystine kidney stones.

• Being able and willing to provide consent.

Exclusion Criteria:

• Poorly controlled diabetes mellitus (hemoglobin A1C > 8.0% for more than 1 year).

• Current alpha-lipoic acid administration at the time of screening or within the last year prior to screening.

• Vulnerable populations including incarceration status.

• Unable to give informed consent.

• Non-English primary language.

• Pregnancy, lactation, or child-bearing age without birth control devices.

• Anticipation of pregnancy during the study period.

• Serious illness likely to cause death within the next 5 years.