Assessing the Impact of a Bile Acid Sequestrant on Serum PFAS Levels in Highly Exposed Individuals
University of California, San Francisco
Summary
This randomized, placebo-controlled crossover trial will test the feasibility and acceptability of using colesevelam in male firefighters with high per- and polyfluoroalkyl substances (PFAS) exposure. This trial will also explore whether colesevelam lowers blood PFAS levels and urine environmental toxicant and mold mycotoxin levels.
Description
Firefighters experience elevated exposure to per- and polyfluoroalkyl substances (PFAS) through firefighting foams, turnout gear, and dust in fire stations. PFAS persist in the body due to their long biological half-lives, leading to bioaccumulation and raising concern for adverse effects on hormone regulation, immune function, reproduction, and cancer risk. Despite growing awareness, there are no approved treatment options to reduce PFAS levels in humans. Bile acid sequestrants, such as colesevelam, bind bile acids in the gastrointestinal tract and may interrupt enterohepatic recirculation of…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Male firefighter, active or retired * California resident * Age 18 or older * English-speaking * Access to a reliable internet connection * Willing to attend 3 in-person study visits in the San Francisco Bay Area over about 6.5 months * Willing to receive weekly text message reminders to complete online surveys * Willing to complete a mail-based, at-home finger-prick blood test * Willing to take 3 tablets (each tablet about the size of a multivitamin) orally twice daily for a total of 6 months * Evaluated by study team to have an elevated risk of PFAS exposure (e.g., dur…
Interventions
- DrugColesevelam
Colesevelam in 625-mg tablets. Participants will take 3 tablets orally, twice daily (total daily dose 3.75 g) for 12 weeks.
- DrugPlacebo
Matching inert oral tablets designed to mimic colesevelam 625 mg tablets in size, shape, and color, but containing no active pharmaceutical ingredient. Participants will take 3 orally, twice per day for 12 weeks.
Location
- UCSF Osher Center for Integrative HealthSan Francisco, California