Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Georgetown University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Georgetown University
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00810368
First received: December 17, 2008
Last updated: February 7, 2011
Last verified: February 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 17, 2008 | ||||||||
| Last Updated Date | February 7, 2011 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00810368 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI) | ||||||||
| Official Title ICMJE | Carnosine in Gulf War Illness (GWI) | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Gulf War Illness | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 258 | ||||||||
| Estimated Completion Date | July 2011 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 34 Years to 82 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00810368 | ||||||||
| Other Study ID Numbers ICMJE | 2008-068, USAMRMC PR# W91ZSQ-7149-N602, HRPO Log No. A-14542.2 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | James N. Baraniuk, MD, Georgetown University | ||||||||
| Study Sponsor ICMJE | Georgetown University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Georgetown University | ||||||||
| Verification Date | February 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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