Phase 2 Completed N=50 Randomized Quadruple-blind Prevention

Lipoic Acid Supplement for Cystine Stone

Cystinuria

Source: ClinicalTrials.gov NCT02910531 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcomePrimary: Cystine Stone Recurrence — 16; 23 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cystine Stone Recurrence	16; 23	—
SECONDARY Urinary Cystine Level	0.8; 0.6	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.