Phase 2
N=33
Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
Persian Gulf Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00810368 ↗Enrolled (actual)
33
Serious AEs
4.0%
Results posted
Aug 2016
Primary outcome: Primary: Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores — -3.8; -2.0 units on a scale — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carnosine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 34+ yrs
- Sex
- All
- Sponsor
- Georgetown University
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores |
-3.8; -2.0 | 0.30 |
| PRIMARY Subjects With Improved Diarrhea Symptoms |
5; 1 | 0.018 sig |
| PRIMARY Incremental Change in Fatigue Score From Baseline to Week 12 |
0.3; -0.6 | — |
| PRIMARY SF36 Bodily Pain |
5.6; -0.5 | 0.5 |
| PRIMARY Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12 |
0.2; -0.9 | 0.5 |
| PRIMARY Incremental Change in SF36 General Health Between Baseline and Week 12 |
0.5; 6.5 | 0.50 |
| SECONDARY Digit Symbol Substitution (WAIS) |
10.8; 2.7 | 0.0018 sig |
Summary
The purpose of this study is to perform a randomized double-blind, placebo-controlled, 12 week study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle strength outcomes in 100 GWI subjects.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00810368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.