"Immunomodulation in GWI (Phlebotomy)"

NCT04058275 | Unknown

• 1 other identifier: 2018-0470
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Gulf War Illness and deployed veterans of the 1990-1991 Persian Gulf War are invited to have a brief history and physical examination to determine their health status, complete questionnaires, then donate about 83 ml of blood. There is no follow-up

Conditions

Gulf War Illness

Outcome Measures

Primary Outcomes (1)

• Gene expression in peripheral blood mononuclear cells

  Determine mRNA expression in peripheral blood mononuclear cells (PBMCs)

  After study recruitment, phleobotomy and mRNA quantification for all participants has been completed in June 2020

Study Arms (2)

Control

Deployed to 1990-1991 Persian Gulf War Do not meet Kansas Criteria for Gulf War Illness \[Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000 Nov 15; 152:992-1002. PubMed PMID: 11092441.\] Good general medical and psychiatric health

Other: Draw blood (phlebotomy, 83 ml)

Gulf War Illness

Deployed to 1990-1991 Persian Gulf War Meet Kansas Criteria for Gulf War Illness \[Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000 Nov 15; 152:992-1002. PubMed PMID: 11092441.\] plus Center for Disease Control criteria for Chronic Multisymptom Illness (CMI) \[Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8. PubMed PMID: 9749480.\]

Other: Draw blood (phlebotomy, 83 ml)

Interventions

Draw blood (phlebotomy, 83 ml) OTHER

Draw 83 ml of blood

Also known as: phlebotomy

Control; Gulf War Illness

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Deployed veterans

You may qualify if:

• Kansas Criteria for GWI
• CDC criteria for CMI

You may not qualify if:

• Chronic medical or psychiatric disorder that may be responsible for symptoms of GWI

Sponsors & Collaborators

• Georgetown University: lead
• Nova Southeastern University: collaborator

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007-2197, United States

RECRUITING

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• James N Baraniuk, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James N Baraniuk, MD

CONTACT

12026878231; baraniuj@georgetown.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 15, 2019
• Study Start: September 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2021
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

US (1)