Phase 2
N=50
Lipoic Acid Supplement for Cystine Stone
Cystinuria
Bottom Line
View on ClinicalTrials.gov: NCT02910531 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Cystine Stone Recurrence — 16; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alpha lipoic acid (Dietary_supplement); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Chi, MD
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cystine Stone Recurrence |
16; 23 | — |
| SECONDARY Urinary Cystine Level |
0.8; 0.6 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02910531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.