Gulf War IllnessNCT04058275
"Immunomodulation in GWI (Phlebotomy)"
An observational study of Gulf War Illness, run by Georgetown University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Draw blood (phlebotomy, 83 ml)
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Deployed veterans
Who may be able to join
- Kansas Criteria for GWI
- CDC criteria for CMI
Who cannot join
- Chronic medical or psychiatric disorder that may be responsible for symptoms of GWI
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20007-2197
James N Baraniuk, MD
About this study
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.
- Conditions
- Gulf War Illness
- Being tested
- Draw blood (phlebotomy, 83 ml)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Draw blood (phlebotomy, 83 ml)Other
Also called phlebotomy
Draw 83 ml of blood
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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.] Receives: Other: Draw blood (phlebotomy, 83 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression in peripheral blood mononuclear cells
Determine mRNA expression in peripheral blood mononuclear cells (PBMCs)
Measured: After study recruitment, phleobotomy and mRNA quantification for all participants has been completed in June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Sep 2018
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Southeastern University
- Responsible party
- Sponsor
- Investigators
- James N Baraniuk, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058275
- Sponsor's protocol ID
- 2018-0470
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cell counts and mRNA levels in peripheral blood mononuclear cells will be available for analysis by contacting the PI
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Immunomodulation in GWI (Phlebotomy)"
- ClinicalTrials.gov ID
- NCT04058275
- Acronym / sponsor ID
- 2018-0470
- Conditions
- Gulf War Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Nova Southeastern University
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: 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 | – | Other: 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.] |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Deployed veterans
Key inclusion criteria (2 listed)
- Kansas Criteria for GWI
- CDC criteria for CMI
Key exclusion criteria (1 listed)
- Chronic medical or psychiatric disorder that may be responsible for symptoms of GWI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Draw blood (phlebotomy, 83 ml)Also: phlebotomyDraw 83 ml of blood | Other | Control, Gulf War Illness |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: Undecided. Cell counts and mRNA levels in peripheral blood mononuclear cells will be available for analysis by contacting the PI
Related trials for Gulf War Illness
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Gulf War Illness, Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James N Baraniuk, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gulf War Illness, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James N Baraniuk, MD (12026878231, baraniuj@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.