"Immunomodulation in GWI (Phlebotomy)"

NCT ID: NCT04058275

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Gulf War Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Draw blood (phlebotomy, 83 ml)

Intervention Type OTHER

Draw 83 ml of blood

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

Draw blood (phlebotomy, 83 ml)

Intervention Type OTHER

Draw 83 ml of blood

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Draw blood (phlebotomy, 83 ml)

Draw 83 ml of blood

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

phlebotomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nova Southeastern University

OTHER

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James N Baraniuk, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Georgetown University

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

James N Baraniuk, MD

Role: CONTACT

12026878231

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

James N Baraniuk, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-0470

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.