"Immunomodulation in GWI (Phlebotomy)"

August 14, 2019 updated by: Georgetown University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007-2197
        • Recruiting
        • Georgetown University
        • Contact:
          • James N Baraniuk, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Deployed veterans

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Draw 83 ml of blood
Other Names:
  • phlebotomy
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)
Draw 83 ml of blood
Other Names:
  • phlebotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression in peripheral blood mononuclear cells
Time Frame: 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)
After study recruitment, phleobotomy and mRNA quantification for all participants has been completed in June 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Nova Southeastern University

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 Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ANTICIPATED)

August 31, 2020

Study Completion (ANTICIPATED)

August 31, 2021

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (ACTUAL)

August 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-0470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Cell counts and mRNA levels in peripheral blood mononuclear cells will be available for analysis by contacting the PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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