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

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
James Baraniuk, MD, Georgetown University
ClinicalTrials.gov Identifier:
NCT00810225
First received: December 17, 2008
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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
Gulf War Illness
Persian Gulf War Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: CNDP1 Polymorphisms in Gulf War Illness (GWI)

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Biospecimen Retention:   Samples With DNA

Plasma, serum, urine, and buccal swab samples retained for testing as described in protocol.


Estimated Enrollment: 516
Study Start Date: August 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: December 17, 2008
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by 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:
Persian Gulf Syndrome
Occupational Diseases

ClinicalTrials.gov processed this record on April 16, 2014