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

Sponsor
Georgetown University (Other)
Overall Status
Completed
CT.gov ID
NCT00810225
Collaborator
U.S. Army Medical Research and Development Command (U.S. Fed)
516
1
35
14.8

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Aug 1, 2008
    Actual Primary Completion Date :
    Jul 1, 2011
    Actual Study Completion Date :
    Jul 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Georgetown University Washington District of Columbia United States 20007

      Sponsors and Collaborators

      • Georgetown University
      • U.S. Army Medical Research and Development Command

      Investigators

      • Principal Investigator: James N Baraniuk, MD, Georgetown University

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      Responsible Party:
      James Baraniuk, MD, Professor of Medicine, Georgetown University
      ClinicalTrials.gov Identifier:
      NCT00810225
      Other Study ID Numbers:
      • 2008-012
      • USAMRMC PR# W81XWH-07-1-0618
      • HRPO Log No. A-14542.1
      First Posted:
      Dec 18, 2008
      Last Update Posted:
      Jun 18, 2018
      Last Verified:
      Jun 1, 2018

      Study Results

      No Results Posted as of Jun 18, 2018