"Immunomodulation in GWI (Phlebotomy)"

• Conditions: Gulf War Illness
• Interventions: Other: Draw blood (phlebotomy, 83 ml)

• Registration Number: NCT04058275
• Lead Sponsor: Georgetown University

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-14
• Last Update Submitted: 2019-08-14
• Study First Posted: 2019-08-15
• Last Update Posted: 2019-08-15
• Primary Completion: 2020-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Kansas Criteria for GWI
• CDC criteria for CMI

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Draw blood (phlebotomy, 83 ml)	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
Gulf War Illness	Draw blood (phlebotomy, 83 ml)	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) \[Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8. PubMed PMID: 9749480.\]

Primary Outcome Measures

Name	Time	Method
Gene expression in peripheral blood mononuclear cells	After study recruitment, phleobotomy and mRNA quantification for all participants has been completed in June 2020	Determine mRNA expression in peripheral blood mononuclear cells (PBMCs)

Trial Locations

Locations (1)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States