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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00810225
Other study ID # 2008-012
Secondary ID USAMRMC PR# W81X
Status Completed
Phase
First received
Last updated
Start date August 2008
Est. completion date July 2011

Study information

Verified date June 2018
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 516
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Locations

Country Name City State
United States Georgetown University Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Georgetown University U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

References & Publications (5)

Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22. — View Citation

Casado B, Zanone C, Annovazzi L, Iadarola P, Whalen G, Baraniuk JN. Urinary electrophoretic profiles from chronic fatigue syndrome and chronic fatigue syndrome/fibromyalgia patients: a pilot study for achieving their normalization. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Jan 5;814(1):43-51. — View Citation

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. — View Citation

Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastañaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. Erratum in: Am J Epidemiol. 2005 Feb 1;161(3):302. — View Citation

Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Köppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7. — View Citation

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