CClinicalTrials.gg
Status unknownNCT04058275Updated Aug 15, 2019

"Immunomodulation in GWI (Phlebotomy)"

An observational study in Gulf War Illness, sponsored by Georgetown University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-15.

Sponsored by Georgetown University · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Gulf War Illness
03

In context

Lead sponsor

Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Deployed veterans

Inclusion criteria

  • Kansas Criteria for GWI
  • CDC criteria for CMI

Exclusion criteria

Exclusion Criteria:

  • Chronic medical or psychiatric disorder that may be responsible for symptoms of GWI
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherDraw blood (phlebotomy, 83 ml)

    Draw 83 ml of blood

    Also known as: phlebotomy

06

What researchers measure

Primary outcomes

  1. Gene expression in peripheral blood mononuclear cells

    Determine mRNA expression in peripheral blood mononuclear cells (PBMCs)

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

07

Study locations

1 of 1 sites recruiting
  • Georgetown University
    Washington, District of Columbia 20007-2197, United States
    • James N Baraniuk, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Cell counts and mRNA levels in peripheral blood mononuclear cells will be available for analysis by contacting the PI

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04058275
Lead sponsor
Georgetown University
Collaborators
Nova Southeastern University
Responsible party
Sponsor
First posted
Aug 15, 2019
Start date
Sep 1, 2018
Primary completion
Aug 31, 2020 (estimated)
Completion
Aug 31, 2021 (estimated)
Last update
Aug 15, 2019

Study contacts

James N Baraniuk, MD
Contact
baraniuj@georgetown.edu
12026878231
James N Baraniuk, MD
principal investigator · Georgetown University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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