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
  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 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
Responsible Party: James Baraniuk, MD, Professor of Medicine, Georgetown University
ClinicalTrials.gov 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:
Carnosine
antioxidant
Persian Gulf War
Gulf War Syndrome
GWI
Gulf War Illness
Exercise
Chronic Fatigue
Fibromyalgia
Veterans
Irritable Bowel Syndrome
Migraine headaches
Neuropathy
Multiple Chemical Sensitivity

ClinicalTrials.gov processed this record on July 20, 2014