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Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Baraniuk, MD, Georgetown University
ClinicalTrials.gov Identifier:
NCT00810368
First received: December 17, 2008
Last updated: February 24, 2014
Last verified: February 2014

December 17, 2008
February 24, 2014
August 2008
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00810368 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
Carnosine in Gulf War Illness (GWI)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gulf War Illness
  • Drug: Carnosine
    500mg Carnosine x2 daily
    Other Name: Pathway Carnosine supplied by Village Green Apothecary
  • Drug: Placebo
    Microcrystalline cellulose placebo tablets x2 daily
    Other Name: Village Green Apothecary
  • Active Comparator: 1
    Carnosine treatment group
    Intervention: Drug: Carnosine
  • Placebo Comparator: 2
    Placebo control group
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
34 Years to 82 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00810368
2008-068, USAMRMC PR# W91ZSQ-7149-N602, HRPO Log No. A-14542.2
No
James Baraniuk, MD, Georgetown University
Georgetown University
Not Provided
Principal Investigator: James N Baraniuk, MD Georgetown University
Georgetown University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP