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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: July 8, 2016
Last verified: July 2016
Results First Received: March 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Persian Gulf Syndrome
Interventions: Drug: Carnosine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Carnosine Treatment Group A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
Placebo Control Group A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.

Participant Flow:   Overall Study
    Carnosine Treatment Group   Placebo Control Group
STARTED   18   15 
COMPLETED   12   13 
NOT COMPLETED   6   2 
Lost to Follow-up                4                2 
Lack of Efficacy                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Prior 2-back working memory scores in Gulf War Illness were an average of 17 out of 35 correct (5=95%CI). Sample size for a 50% increase in 2-back working memory scores was 13 per group. 10% per month drop out rate was predicted so our aim was to have 36 subjects enter the study.

Reporting Groups
  Description
Carnosine Treatment Group A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
Placebo Control Group A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Carnosine Treatment Group   Placebo Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   15   33 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.8  (11.6)   47.2  (8.7)   49.5  (10.2) 
Gender 
[Units: Participants]
     
Female   4   5   9 
Male   14   10   24 
Region of Enrollment 
[Units: Participants]
     
United States   18   15   33 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores   [ Time Frame: Weeks 0 and 12 ]

2.  Primary:   Subjects With Improved Diarrhea Symptoms   [ Time Frame: Weeks 0 and 12 ]

3.  Primary:   Incremental Change in Fatigue Score From Baseline to Week 12   [ Time Frame: Week 0 and Week 12 ]

4.  Primary:   SF36 Bodily Pain   [ Time Frame: Week 0 and Week 12 ]

5.  Primary:   Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12   [ Time Frame: Week 0 and Week 12 ]

6.  Primary:   Incremental Change in SF36 General Health Between Baseline and Week 12   [ Time Frame: Week 0 and Week 12 ]

7.  Secondary:   Digit Symbol Substitution (WAIS)   [ Time Frame: Difference between Week 0 and Week 12 (end of study) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Small sample sizes. No measure of changes in brain carnosine/homocarnosine/GABA.

Subjective outcomes were insensitive to change. Stool consistency needed better scoring system.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. James N Baraniuk
Organization: Georgetown University Medical Center
phone: 202-687-8231
e-mail: baraniuklab@gmail.com


Publications of Results:
Other Publications:

Responsible Party: James Baraniuk, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00810368     History of Changes
Other Study ID Numbers: 2008-068
USAMRMC PR# W91ZSQ-7149-N602 ( Other Grant/Funding Number: CDMRP, DoD )
HRPO Log No. A-14542.2 ( Other Identifier: Human Research Protection Office protocol number )
Study First Received: December 17, 2008
Results First Received: March 24, 2014
Last Updated: July 8, 2016