GWICTIC: NAC Mechanistic Study in Gulf War Veterans

Part of paid clinical trials in Palo Alto, California.

Sponsor
Nova Southeastern University
Study ID
NCT04987775
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Gulf War Syndrome

Eligibility Criteria

Sex
ALL
Age
47 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • N-Acetyl Cysteine — DRUG
    900mg 2x daily
  • Placebo — DRUG
    Matching placebo bid

Study Details

This mechanistic study will test if NAC affects chronic oxidative stress and depletion of antioxidants in GWI participants. Blood specimen collection and neuroimaging will be used to determine whether NAC affects serum glutathione (GSH) concentration and oxidative stress in the CNS when compared to placebo.

Key Dates

Start date
Nov 30, 2023
Status verified
Jul 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: N-Acetyl Cysteine (NAC)
    Participants who are randomized to the intervention arm will receive N-Acetyl-L-Cysteine (Free-Form/NAC) 900mg two times a day for 8 weeks after the initiation of the first dose of study drug.
  • Placebo Comparator: Placebo
    Participants who are randomized to the placebo arm will take matching placebo two times a day for 8 weeks after the initiation of the first dose of study drug.

Primary Outcome Measure

Assess glutathione levels [ Time Frame: Baseline to 8 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care System War Related Illness and Injury Study CenterPalo AltoCalifornia94304
Wes Ashford, MD
[email protected]
650-852-3316
Wes Ashford, MD (PRINCIPAL_INVESTIGATOR)
Nova Southeastern UniversityFort LauderdaleFlorida33314
Nancy Klimas, MD
[email protected]
Amaanpreet Cheema, PhD
[email protected]
Nancy Klimas, MD (PRINCIPAL_INVESTIGATOR)
Amaanpreet Cheema, PhD (SUB_INVESTIGATOR)
Boston University Medical SchoolBostonMassachusetts02215-
VA New Jersey Health Care System War Related Illness and Injury Study CenterEast OrangeNew Jersey07018
Helena Chandler, PhD
[email protected]
973-676-3580
Helena Chandler, PhD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CollegeNew YorkNew York10021-
RTI InternationalDurhamNorth Carolina27709-
Michael E. DeBakey VA Medical CenterHoustonTexas77030
Drew Helmer, MD
[email protected]
713-440-4452
Drew Helmer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By research site
VA Palo Alto Health Care System War Related Illness and Injury Study Center· Palo Alto, CANova Southeastern University· Fort Lauderdale, FLBoston University Medical School· Boston, MAVA New Jersey Health Care System War Related Illness and Injury Study Center· East Orange, NJWeill Cornell Medical College· New York, NYRTI International· Durham, NC

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