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Study of Gulf War Illness (GWI) by Comparing GWI and Healthy Veterans

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ClinicalTrials.gov Identifier: NCT00810225
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
James Baraniuk, MD, Georgetown University

Brief Summary:

Determine if:

  • genetic differences of CNDP1 gene
  • the previously defined GWI/Chronic Fatigue Syndrome (GWI/CFS) cerebrospinal fluid proteome contents
  • psychometric
  • other variables can differentiate between veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms and those without these complaints.

Condition or disease
Gulf War Illness Persian Gulf War Syndrome

Study Type : Observational
Actual Enrollment : 516 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: CNDP1 Polymorphisms in Gulf War Illness (GWI)
Study Start Date : August 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Group/Cohort
1
GWI: veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
2
HC: healthy veterans of the 1990-1991 Persian Gulf War



Biospecimen Retention:   Samples With DNA
Plasma, serum, urine, and buccal swab samples retained for testing as described in protocol.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All veterans who served in the Armed Forces between August 1990 and July 1991
Criteria

Inclusion Criteria:

  • Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:

    • Persian Gulf waters and adjacent land areas
    • Other global locations
    • U.S. only
  • Status prior to 1990 and 1991:

    • Active duty
    • National Guard
    • Reserves

Exclusion Criteria:

  • Current active duty military personnel
  • Any one who was not active duty military personnel between August 1, 1990 and July 31, 1991
  • HIV/AIDS; pregnancy or lactation; potential hepatitis; drug addiction; chronic inflammatory, infectious, or autoimmune medical illnesses not associated with GWI; incarceration; dementia, other cognitive limitation; or reliance on a care-giver in order to respond to the questionnaires and other study tests.

Amputations of one or both hands and forearms will be permitted but hand grip tests will not be tested


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810225


Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: James N Baraniuk, MD Georgetown University

Additional Information:
Publications:
Responsible Party: James Baraniuk, MD, Professor of Medicine, Georgetown University
ClinicalTrials.gov Identifier: NCT00810225     History of Changes
Other Study ID Numbers: 2008-012
USAMRMC PR# W81XWH-07-1-0618
HRPO Log No. A-14542.1
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Keywords provided by James Baraniuk, MD, Georgetown University:
CNDP1
carnosine dipeptidase 1
Persian Gulf War
Gulf War Syndrome
GWI
Gulf War Illness
Exercise
Chronic Fatigue
Fibromyalgia
Veterans
Irritable Bowel Syndrome
Migraine headaches
Neuropathy
Multiple Chemical Sensitivity

Additional relevant MeSH terms:
Syndrome
Persian Gulf Syndrome
Disease
Pathologic Processes
Occupational Diseases