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

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

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ]

Enrollment: 150
Study Start Date: August 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Carnosine treatment group
Drug: Carnosine
500mg Carnosine x2 daily
Other Name: Pathway Carnosine supplied by Village Green Apothecary
Placebo Comparator: 2
Placebo control group
Drug: Placebo
Microcrystalline cellulose placebo tablets x2 daily
Other Name: Village Green Apothecary


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

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:

  • Pregnant Women
  • Active Duty Military Personnel
  • Children
  • Incarceration
  Contacts and Locations
Please refer to this study by its identifier: NCT00810368

United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Principal Investigator: James N Baraniuk, MD Georgetown University
  More Information

Additional Information:
Responsible Party: James Baraniuk, MD, Professor of Medicine, Georgetown University Identifier: NCT00810368     History of Changes
Other Study ID Numbers: 2008-068, USAMRMC PR# W91ZSQ-7149-N602, HRPO Log No. A-14542.2
Study First Received: December 17, 2008
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Georgetown University:
Persian Gulf War
Gulf War Syndrome
Gulf War Illness
Chronic Fatigue
Irritable Bowel Syndrome
Migraine headaches
Multiple Chemical Sensitivity processed this record on April 20, 2014