RECRUITING

GWICTIC: NAC Mechanistic Study in Gulf War Veterans

Conditions

Gulf War Syndrome CNS Recovery N-Acetyl Cysteine (NAC)Gulf War Illness Placebo

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanisms of Oxidative Stress During N-Acetyl Cysteine (NAC) Supplementation in Veterans With Gulf War Illness (GWI)

Quick Facts

Study Start:2023-11-30

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04987775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:47 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 47 to 70 years * Served in the Gulf War Theater for any period between August 1990 and July 1991. * Meets modified Kansas case definition criteria for Gulf War Illness. The modified Kansas definition includes the following: 1. Allowance of normal illness of aging, such as hypertension and diabetes, if the conditions are treated and are in demonstrable stable and normal ranges at the time of screening and assessment. 2. Allowance of stable comorbid conditions such as Post Traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD), and mild Traumatic Brain Injury (mTBI) that have not required hospitalization in the 2 years prior to recruitment. Severe TBI is excluded. * Able to provide written consent to the study * Agrees to participate in follow-up visits.	* Self-report of current treated or untreated major depression with psychotic or melancholic features (as determined by self-report and Hamilton Depression Inventory (Ham-D)), schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or a history of central nervous system (CNS) disorders that may affect cognitive function (e.g., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease), or alcoholism or drug abuse * Severe claustrophobia or serious difficulty being in an MRI scanner or other enclosed space (MRS substudy only) * Presence of ferrous implanted medical devices or metal fragments or objects that are embedded under the skin (MRS substudy only) * Current heavy alcohol or tobacco use (self-report). Alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day. * Chronic active infections such as HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) (self-report or antibody titer) * Renal disease (self-report or laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL) * Liver disease (self-report or laboratory results: hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \> 3 times the upper limits of normal) * Uncontrolled diabetes (HgbA1c \> 7.5) without adequate medical care. Individuals with HgbA1c \> 7.5 will be reviewed and judged by the PI or delegate; if potential participant has adequate medical care to manage diabetes, enrollment is allowed; otherwise HgbA1c \> 7.5 is exclusionary * Diagnosed vascular disease (including congestive heart failure) * Diagnosed bleeding disorders or use of blood-thinning medications * Receipt of stavudine or didanosine for more than 7 days within 30 days prior to screening * Currently have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity * Are scheduled for a surgery during the period of study participation or had surgery within 6 weeks prior to screening * Pregnant (women only) * Currently on dialysis * Previous or current receipt of any antiviral medication, such as pegylated interferon, ribavirin, entecavir, tenofovir, or didanosine for more than 7 days within 30 days prior to screening * Participating in another interventional (including social-behavioral therapy) clinical trial of an investigational therapy within 6 weeks prior to consent, or planning to participate in another interventional clinical trial of an investigational therapy during the course of this study * Any herbal medicine within 30 days prior to consent and screening blood draw

Inclusion Criteria

Exclusion Criteria

* 47 to 70 years
* Served in the Gulf War Theater for any period between August 1990 and July 1991.
* Meets modified Kansas case definition criteria for Gulf War Illness. The modified Kansas definition includes the following:
1. Allowance of normal illness of aging, such as hypertension and diabetes, if the conditions are treated and are in demonstrable stable and normal ranges at the time of screening and assessment.
2. Allowance of stable comorbid conditions such as Post Traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD), and mild Traumatic Brain Injury (mTBI) that have not required hospitalization in the 2 years prior to recruitment. Severe TBI is excluded.
* Able to provide written consent to the study
* Agrees to participate in follow-up visits.

* Self-report of current treated or untreated major depression with psychotic or melancholic features (as determined by self-report and Hamilton Depression Inventory (Ham-D)), schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or a history of central nervous system (CNS) disorders that may affect cognitive function (e.g., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease), or alcoholism or drug abuse
* Severe claustrophobia or serious difficulty being in an MRI scanner or other enclosed space (MRS substudy only)
* Presence of ferrous implanted medical devices or metal fragments or objects that are embedded under the skin (MRS substudy only)
* Current heavy alcohol or tobacco use (self-report). Alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day.
* Chronic active infections such as HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) (self-report or antibody titer)
* Renal disease (self-report or laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL)
* Liver disease (self-report or laboratory results: hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \> 3 times the upper limits of normal)
* Uncontrolled diabetes (HgbA1c \> 7.5) without adequate medical care. Individuals with HgbA1c \> 7.5 will be reviewed and judged by the PI or delegate; if potential participant has adequate medical care to manage diabetes, enrollment is allowed; otherwise HgbA1c \> 7.5 is exclusionary
* Diagnosed vascular disease (including congestive heart failure)
* Diagnosed bleeding disorders or use of blood-thinning medications
* Receipt of stavudine or didanosine for more than 7 days within 30 days prior to screening
* Currently have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity
* Are scheduled for a surgery during the period of study participation or had surgery within 6 weeks prior to screening
* Pregnant (women only)
* Currently on dialysis
* Previous or current receipt of any antiviral medication, such as pegylated interferon, ribavirin, entecavir, tenofovir, or didanosine for more than 7 days within 30 days prior to screening
* Participating in another interventional (including social-behavioral therapy) clinical trial of an investigational therapy within 6 weeks prior to consent, or planning to participate in another interventional clinical trial of an investigational therapy during the course of this study
* Any herbal medicine within 30 days prior to consent and screening blood draw

Contacts and Locations

Study Contact

Nancy Klimas, MD

CONTACT

9542622855

nklimas@nova.edu

Karen Kesler, PhD

CONTACT

kkelser@rti.org

Principal Investigator

Nancy Klimas, MD

PRINCIPAL_INVESTIGATOR

Nova Southeastern Univeristy

Study Locations (Sites)

VA Palo Alto Health Care System War Related Illness and Injury Study Center

Palo Alto, California, 94304

United States

Nova Southeastern University

Fort Lauderdale, Florida, 33314

United States

Boston University Medical School

Boston, Massachusetts, 02215

United States

VA New Jersey Health Care System War Related Illness and Injury Study Center

East Orange, New Jersey, 07018

United States

Weill Cornell Medical College

New York, New York, 10021

United States

RTI International

Durham, North Carolina, 27709

United States

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Nova Southeastern University

Nancy Klimas, MD, PRINCIPAL_INVESTIGATOR, Nova Southeastern Univeristy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-30

Study Completion Date2025-09

Study Record Updates

Study Start Date2023-11-30

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

CNS Recovery
N-Acetyl Cysteine (NAC)
Gulf War Illness
Placebo

Additional Relevant MeSH Terms

Gulf War Syndrome