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.
This double-blind randomized controlled trial has a extended open phase to test the use of oral Colesevelam (3 x 625 mg tablets qd) for 12 weeks to lower total serum PFAS levels in individuals with \>20 ng/ml PFAS. After 12 weeks, participants assigned to placebo will have an opportunity to participate in the intervention of 12 weeks. Participants on the intervention will remain on the intervention for another 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
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
A double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam
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
PFAS content
Reduction PFAS content in serum (total and 7 individual PFAS).
Time frame: 24 weeks
Serum biomarkers
The secondary outcome will be initial and final serum biomarkers related to lipid metabolism.
Time frame: 24 weeks
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