Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI) - Full Text View

Sponsored by:	Georgetown University
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00810368

Purpose

The purpose of this study is to perform a randomized double-blind, placebo-controlled, six month study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle strength outcomes in 100 GWI subjects.

Condition	Intervention	Phase
Gulf War Illness	Drug: Carnosine Drug: Placebo	Phase II

Drug Information available for: Cellulose Cellulose sodium phosphate Phosphocellulose Carnosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Carnosine in Gulf War Illness (GWI)

Further study details as provided by Georgetown University:

Primary Outcome Measures:

Determine if 6 months of oral carnosine 500 mg twice daily has significant, beneficial effects on:(1)activity, 2)cognitive, 3)plasma proteomic outcomes compared to placebo. [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the safety of carnosine 500 mg twice daily in GWI volunteers. [ Time Frame: 09/2011 ] [ Designated as safety issue: Yes ]
Determine if responses to carnosine can be stratified according to "long" versus "short" alleles of the CNDP1 gene. CNDP1 degrades carnosine. [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]
Assess longitudinal changes in the placebo group (natural history of symptom variation in GWI). [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	258
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Carnosine treatment group	Drug: Carnosine 500mg Carnosine x2 daily
2: Placebo Comparator Placebo control group	Drug: Placebo Microcrystalline cellulose placebo tablets x2 daily

Eligibility

Ages Eligible for Study:	34 Years to 82 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, or,
- U.S. only. 1990-1991 enlistment status:
- Active duty
- National Guard
- Reserves

Exclusion Criteria:

HIV/AIDS
Pregnant Women
Active Duty Military Personnel
Children
Incarceration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810368

Contacts

Contact: Samantha J Merck	202-687-8231	gwiresearch@georgetown.edu
Contact: Murugan K Ravindran, MD	202-687-8231	gwiresearch@georgetown.edu

Locations

United States, District of Columbia
Georgetown University	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Samantha J Merck 202-687-8231 gwiresearch@georgetown.edu
Principal Investigator: James N Baraniuk, MD

Sponsors and Collaborators

Georgetown University

Investigators

Principal Investigator:

James N Baraniuk, MD

Georgetown University

More Information

Publications:

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.

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.

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.

Chez MG, Buchanan CP, Aimonovitch MC, Becker M, Schaefer K, Black C, Komen J. Double-blind, placebo-controlled study of L-carnosine supplementation in children with autistic spectrum disorders. J Child Neurol. 2002 Nov;17(11):833-7.

Responsible Party:	Georgetown University ( James N. Baraniuk, MD )
Study ID Numbers:	IRB-2008-068, USAMRMC PR# W91ZSQ-7149-N602, HRPO Log No. A-14542.2
Study First Received:	December 17, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00810368
Health Authority:	United States: Food and Drug Administration; United States: Federal Government

Keywords provided by Georgetown University:

Carnosine
GWI
Gulf War Illness

ClinicalTrials.gov processed this record on January 14, 2009