Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study (PAVERS)
11. maj 2026 opdateret af: University of Rhode Island
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
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Angela Slitt, PhD
- Telefonnummer: 4018745020
- E-mail: angela_slitt@uri.edu
Studiesteder
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40245
- Robley Rex VA Medical Center
-
Ledende efterforsker:
- Matthew Cave, MD
-
Kontakt:
- Matthew Cave, MD
- Telefonnummer: 5028526189
- E-mail: matthew.cave@louisville.edu
-
-
Maine
-
Augusta, Maine, Forenede Stater, 04330
- VA Maine Healthcare System
-
Kontakt:
- Rodney Sparks, MD
- Telefonnummer: (207) 623-8411
- E-mail: Rodney.Sparks@va.gov
-
Kontakt:
- Vanessa Knipping, MSACN
- Telefonnummer: (207) 623-8411
- E-mail: Vanessa.knipping@va.gov
-
Ledende efterforsker:
- Rodney Sparks, MD
-
Underforsker:
- Angela Slitt, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion:
- Male or female Veterans aged 25- 65 who have serum PFAS >20 ng/ml exceeding National Academy of Science guidance.
- Written informed consent will be obtained.
- Outpatient.
- Agreeable to participate in sharable data and biorepository.
Exclusion:
- Under the age of 25 years
- Unable or unwilling to sign the informed consent statement and HIPAA Authorization form
- Females who are pregnant (confirmed by urine pregnancy test), nursing or planned pregnancy within study period.
- Patients with hypertriglyceridemia, vitamin deficient patients, hyperthyroidism and diabetic, pancreatitis and intestinal and bowel obstruction
- Be receiving any investigational drug other than Colesevelam or participating in any other investigational study.
- Significant medical illnesses that may limit the subject's ability to complete follow-up visits, in the opinion of the investigator.
- Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results.
- Those with significant cardiovascular disease including treatment with inotropes.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Active substance abuse if this, in the opinion of the investigator, will interfere with the subject's ability to adhere to the study protocol.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Colesevelam
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 (3 x 625 mg tablets daily) for 12 weeks
|
|
Placebo komparator: Placebo
Oral placebo (3 x 250 mg once daily) for 12 weeks
|
A double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFAS content
Tidsramme: 24 weeks
|
Reduction PFAS content in serum (total and 7 individual PFAS).
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum biomarkers
Tidsramme: 24 weeks
|
The secondary outcome will be initial and final serum biomarkers related to lipid metabolism.
|
24 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exploratory
Tidsramme: 24 weeks
|
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.
|
24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Angela Slitt, PhD, The University of Rhode Island
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
30. april 2029
Studieafslutning (Anslået)
29. september 2029
Datoer for studieregistrering
Først indsendt
11. maj 2026
Først indsendt, der opfyldte QC-kriterier
11. maj 2026
Først opslået (Faktiske)
18. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AWD
- CDMRP-TX240390 (Andet bevillings-/finansieringsnummer: Congressionally Directed Medical Research Programs (CDMRP))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Ingen
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