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Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study
Sponsor: University of Rhode Island
Summary
The goal of this study is to test the efficacy and feasibility of Colesevelam administration (50% of the recommended dose) to reduce serum PFAS concentration in the Veteran population who have serum PFAS levels that exceed the National Academies Science criteria (PFASsix \> 20 ng/ml) using a double blind-placebo controlled study. Based on PFAS prevalence in serum samples, we anticipate recruiting up to n=500 Veterans to meet the goal of n=50 study participants to receive intervention or placebo. The primary outcome will be initial and final PFAS content in serum (total and 7 individual PFAS). The secondary outcome will be initial and final serum biomarkers related to lipid metabolism. As an exploratory aspect to the proposal, we will also measure fecal PFAS, bile acids, and microbial diversity to examine associations between PFAS content and bile acid levels and microbiome. Fecal PFAS, bile acid content, and microbiome may also be measured.
Official title: Use of Bile Acid Binding Resins to Decrease Systemic Per- and Polyfluoroalkyl Substance (PFAS) Levels and Improve Serum Lipid Profiles in Veterans: PFAS Reduction in Veterans Via Colesevalem Study (PAVERS) Study
Key Details
Gender
All
Age Range
25 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-07-01
Completion Date
2029-09-29
Last Updated
2026-05-18
Healthy Volunteers
Yes
Conditions
Interventions
Colesevelam
A double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam (3 x 625 mg tablets daily) for 12 weeks
Placebo
A double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam
Locations (3)
Robley Rex VA Medical Center
Louisville, Kentucky, United States
VA Maine Healthcare System
Augusta, Maine, United States
VA Maine Healthcare System
Augusta, Maine, United States