"Immunomodulation in GWI (Phlebotomy)"

Gulf War Illness Clinical Trial

Official title:

"Immunomodulation in GWI (Phlebotomy)"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058275
• Other study ID #: 2018-0470
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: August 2019
• Source: Georgetown University
• Contact: James N Baraniuk, MD
• Phone: 12026878231
• Email: baraniuj[@]georgetown.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gulf War Illness

Intervention

Other:
• Draw blood (phlebotomy, 83 ml)
Draw 83 ml of blood

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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