Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
NCT ID: NCT00810368
Last Updated: 2019-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2008-08-31
2012-07-31
Brief Summary
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Detailed Description
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Drug: Homocarnosine is not available. Carnosine (beta-alanine - histidine) is an over-the-counter dietary supplement that shares the antioxidant properties. We proposed that oral carnosine would be absorbed from the gut, cross the blood brain barrier, reduce presumed brain oxidant stress that participated in illness pathology, and improve subject health.
Hypothesis: Carnosine supplementation for 12 weeks by mouth in Gulf War Illness subjects would improve cognitive and other outcomes compared to placebo treatment.
Subjects: Gulf War Illness subjects met 1996 Fukuda criteria for Chronic Multisymptom Illness.
Design: Pilot study. Double blind randomized placebo controlled with comparisons between Week 0 (Baseline, pre-randomization) and Week 12 (end of study) Outcomes: This pilot study included included cognitive testing, magnetic resonance imaging during the 2-back working memory task, self-report of psychometric and other subjective symptoms, tenderness testing by dolormetry, and pain threshold to assess reproducibility in the placebo-treated subjects, and potential treatment effects in the active study drug subjects. The study and each of the outcomes at weeks 0 and 12 are described in detail in the final published paper and in its extensive supplementary on-line materials (Baraniuk JN et al. Glob J Health Sci. 2013 5:69-81. PMID:23618477 PMCID:PMC4209301).
An improvement on accuracy on the 2-back working memory task between 0 and 12 weeks was the primary outcome.
Other evaluations were secondary outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Carnosine treatment group
Carnosine treatment group
Carnosine
500mg Carnosine x2 daily
Placebo control group
Placebo control group
Placebo
Microcrystalline cellulose placebo tablets x2 daily
Interventions
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Carnosine
500mg Carnosine x2 daily
Placebo
Microcrystalline cellulose placebo tablets x2 daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant Women
* Active Duty Military Personnel
* Children
* Incarceration
34 Years
82 Years
ALL
No
Sponsors
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Georgetown University
OTHER
Responsible Party
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James Baraniuk, MD
Professor of Medicine
Principal Investigators
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James N Baraniuk, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Georgetown University
Washington D.C., District of Columbia, United States
Countries
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References
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Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastanaga 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. doi: 10.1093/aje/155.11.1033.
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. doi: 10.1186/1471-2377-5-22.
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, Koppel 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. doi: 10.2337/diabetes.54.8.2320.
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. doi: 10.1177/08830738020170111501.
Baraniuk JN, El-Amin S, Corey R, Rayhan R, Timbol C. Carnosine treatment for gulf war illness: a randomized controlled trial. Glob J Health Sci. 2013 Feb 4;5(3):69-81. doi: 10.5539/gjhs.v5n3p69.
Related Links
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Laboratory Website
Other Identifiers
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USAMRMC PR# W91ZSQ-7149-N602
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HRPO Log No. A-14542.2
Identifier Type: OTHER
Identifier Source: secondary_id
2008-068
Identifier Type: -
Identifier Source: org_study_id
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