Persian Gulf SyndromePhase 2NCT00810368

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

A Phase 2 study testing Carnosine in people with Persian Gulf Syndrome, run by Georgetown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 34 to 82 years
Conditions the study is for: Persian Gulf Syndrome
What is being tested?: Carnosine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Jul 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 34 to 82 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

HIV/AIDS
Pregnant Women
Active Duty Military Personnel
Children
Incarceration

Trial locations and contacts

1 site in 1 country.

United States1 site

Georgetown University
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: Carnosine Versus Placebo Treatment Study in Gulf War Illness (GWI)

Read the detailed description

Background: Homocarnosine (beta-alanine - gamma-aminobutyric acid) is one of the most abundant dipeptides in the brain. It has important antioxidant properties. Both beta-alanine and GABA are neurotransmitters, suggesting that cleavage of this dipeptide by carnosine dipeptidase 1 (CNDP1) may have important regulatory functions in vivo.

Drug: Homocarnosine is not available. Carnosine (beta-alanine - histidine) is an over-the-counter dietary supplement that shares the antioxidant properties. We proposed that oral carnosine would be absorbed from the gut, cross the blood brain barrier, reduce presumed brain oxidant stress that participated in illness pathology, and improve subject health.

Hypothesis: Carnosine supplementation for 12 weeks by mouth in Gulf War Illness subjects would improve cognitive and other outcomes compared to placebo treatment.

Subjects: Gulf War Illness subjects met 1996 Fukuda criteria for Chronic Multisymptom Illness.

Design: Pilot study. Double blind randomized placebo controlled with comparisons between Week 0 (Baseline, pre-randomization) and Week 12 (end of study) Outcomes: This pilot study included included cognitive testing, magnetic resonance imaging during the 2-back working memory task, self-report of psychometric and other subjective symptoms, tenderness testing by dolormetry, and pain threshold to assess reproducibility in the placebo-treated subjects, and potential treatment effects in the active study drug subjects. The study and each of the outcomes at weeks 0 and 12 are described in detail in the final published paper and in its extensive supplementary on-line materials (Baraniuk JN et al. Glob J Health Sci. 2013 5:69-81. PMID:23618477 PMCID:PMC4209301).

An improvement on accuracy on the 2-back working memory task between 0 and 12 weeks was the primary outcome.

Other evaluations were secondary outcomes.

Conditions: Persian Gulf Syndrome
Being tested: Carnosine, Placebo
Keywords: 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
Medical subject headings: Persian Gulf Syndrome, Motor Activity, Fibromyalgia, Irritable Bowel Syndrome, Migraine Disorders, Multiple Chemical Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CarnosineDrug
Also called Pathway Carnosine supplied by Village Green Apothecary
500mg Carnosine x2 daily
PlaceboDrug
Also called Village Green Apothecary
Microcrystalline cellulose placebo tablets x2 daily

Study groups in NCT00810368
Study group	Role	What they receive
Carnosine treatment group	Active comparator	Carnosine treatment group Receives: Drug: Carnosine
Placebo control group	Placebo comparator	Placebo control group Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores
CFS Severity Score (Δ ≥ 5 / 36) (Baraniuk et al., 1998; Baraniuk et al., 2000a; Baraniuk, Naranch, Maibach, \& Clauw, 2000b). Subjects scored the severity of the 9 CFS criteria (Fatigue, memory/concentration, sore throat, sore lymph nodes, sore muscles, sore joints, headache, sleep disturbances, exertional exhaustion from Fukuda et al. 1994) on a scale of none (score=0), trivial (1), mild (2), moderate (3) and severe (4). The sum was 36.
Individuals taking carnosine were predicted to show a decrease of ≥ 5 at week 12 compared to week 0, compared to no change for placebo subjects. 2-tailed paired t-tests were used to determine significant incremental changes for individuals in the carnosine group compared to the placebo group.
Measured: Weeks 0 and 12
Subjects With Improved Diarrhea Symptoms
Patients were given questionnaires assessing common symptom complaints of diarrhea.
Measured: Weeks 0 and 12
Incremental Change in Fatigue Score From Baseline to Week 12
Instantaneous Fatigue was scored as none (0) to severe (10) at week 0 and week 12. The difference between the Week 12 minus the Week 0 values was the incremental change. If the incremental change was greater than 0, then the Instantaneous Fatigue was worse at week 12 than week 0. If the incremental change was less than 0, then the Instantaneous Fatigue was improved at week 12 compared to week 0. The total potential range for incremental change was from -10 to +10.
Measured: Week 0 and Week 12
SF36 Bodily Pain
Incremental change in Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score from baseline to week 12. The Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score ranges from 0 (very bad bodily pain) to 100 (no bodily pain). The incremental change was the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at week 12 minus the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.
Measured: Week 0 and Week 12
Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12
Each item on the Generalized Anxiety Scale (GAD) scores was scored as none (0), trivial (1), mild (2), moderate (3), or severe (4) and the sum of the 7 items calculated (range 0 to 28). The incremental change between Week 0 and Week 12 was determined for each treatment.
Measured: Week 0 and Week 12
Incremental Change in SF36 General Health Between Baseline and Week 12
Incremental change in SF36 General Health score from baseline to week 12. The SF36 General Health score ranges from 0 (very bad General Health) to 100 (very good General Health). The incremental change was the SF36 General Health score at week 12 minus the SF36 General Health score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for SF36 General Health score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the SF36 General Health score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.
Measured: Week 0 and Week 12

Secondary outcomes (1)

Digit Symbol Substitution (WAIS)
Digit Symbol Substitution (WAIS) test (Joy et al., 2000): Subjects were given a table of numerals with matching symbols, and a form with random numerals with open spaces. The objective was to write in as many symbols that corresponded to the random numerals within a 90 second period. Each subject was their own control. The outcome measure was the incremental change in this score between Week 0 and Week 12 (units on a scale). Higher scores indicate better performance.
Measured: Difference between Week 0 and Week 12 (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Jul 2012

First posted18 Dec 2008 (estimated)
Study startAug 2008
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Persian Gulf SyndromeStudies of the same condition, open and under way.
More trials run by Georgetown UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00810368
Sponsor's protocol ID: 2008-068
Other IDs: USAMRMC PR# W91ZSQ-7149-N602, HRPO Log No. A-14542.2
Status last verified: Jun 2019
First submitted: 17 Dec 2008
Last updated: 28 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastanaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. doi: 10.1093/aje/155.11.1033.
PubMed 12034582
Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22. doi: 10.1186/1471-2377-5-22.
PubMed 16321154
Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Koppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7. doi: 10.2337/diabetes.54.8.2320.
PubMed 16046297
Chez MG, Buchanan CP, Aimonovitch MC, Becker M, Schaefer K, Black C, Komen J. Double-blind, placebo-controlled study of L-carnosine supplementation in children with autistic spectrum disorders. J Child Neurol. 2002 Nov;17(11):833-7. doi: 10.1177/08830738020170111501.
PubMed 12585724
Baraniuk JN, El-Amin S, Corey R, Rayhan R, Timbol C. Carnosine treatment for gulf war illness: a randomized controlled trial. Glob J Health Sci. 2013 Feb 4;5(3):69-81. doi: 10.5539/gjhs.v5n3p69.
PubMed 23618477

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
Gulf War Syndrome
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Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Gulf War Syndrome
RecruitingPhase 2
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
Gulf War Syndrome, Adult Growth Hormone Deficiency
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
RecruitingPhase 3
Coenzyme Q10 for Gulf War Illness: A Replication Study
Gulf War Syndrome, Persian Gulf Syndrome

All Persian Gulf Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Carnosine Versus Placebo Treatment Study in Gulf War Illness (GWI)
ClinicalTrials.gov ID: NCT00810368
Acronym / sponsor ID: 2008-068
Conditions: Persian Gulf Syndrome
Keywords: Carnosine, antioxidant, Persian Gulf War, Gulf War Syndrome, GWI, Gulf War Illness, Exercise, Chronic Fatigue
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Georgetown UniversityUniversity, hospital or other
Study start: Aug 2008
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 18 Dec 2008 (estimated)
Results: Posted 18 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Hypothesis: Carnosine supplementation for 12 weeks by mouth in Gulf War Illness subjects would improve cognitive and other outcomes compared to placebo treatment.

Subjects: Gulf War Illness subjects met 1996 Fukuda criteria for Chronic Multisymptom Illness.

An improvement on accuracy on the 2-back working memory task between 0 and 12 weeks was the primary outcome.

Other evaluations were secondary outcomes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Carnosine treatment group	Active comparator	Drug: CarnosineCarnosine treatment group
Placebo control group	Placebo comparator	Drug: PlaceboPlacebo control group

Who may qualify

Ages: 34 to 82 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:

Key exclusion criteria (5 listed)

HIV/AIDS
Pregnant Women
Active Duty Military Personnel
Children
Incarceration

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CarnosineAlso: Pathway Carnosine supplied by Village Green Apothecary500mg Carnosine x2 daily	Drug	Carnosine treatment group
PlaceboAlso: Village Green ApothecaryMicrocrystalline cellulose placebo tablets x2 daily	Drug	Placebo control group

Primary outcome

Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores
Time frame: Weeks 0 and 12
CFS Severity Score (Δ ≥ 5 / 36) (Baraniuk et al., 1998; Baraniuk et al., 2000a; Baraniuk, Naranch, Maibach, \& Clauw, 2000b). Subjects scored the severity of the 9 CFS criteria (Fatigue, memory/concentration, sore throat, sore lymph nodes, sore muscles, sore joints, headache, sleep disturbances, exertional exhaustion from Fukuda et al. 1994) on a scale of none (score=0), trivial (1), mild (2), moderate (3) and severe (4). The sum was 36. Individuals taking carnosine were predicted to show a decrease of ≥ 5 at week 12 compared to week 0, compared to no change for placebo subjects. 2-tailed paired t-tests were used to determine significant incremental changes for individuals in the carnosine group compared to the placebo group.
Subjects With Improved Diarrhea Symptoms
Time frame: Weeks 0 and 12
Patients were given questionnaires assessing common symptom complaints of diarrhea.
Incremental Change in Fatigue Score From Baseline to Week 12
Time frame: Week 0 and Week 12
Instantaneous Fatigue was scored as none (0) to severe (10) at week 0 and week 12. The difference between the Week 12 minus the Week 0 values was the incremental change. If the incremental change was greater than 0, then the Instantaneous Fatigue was worse at week 12 than week 0. If the incremental change was less than 0, then the Instantaneous Fatigue was improved at week 12 compared to week 0. The total potential range for incremental change was from -10 to +10.
SF36 Bodily Pain
Time frame: Week 0 and Week 12
Incremental change in Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score from baseline to week 12. The Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score ranges from 0 (very bad bodily pain) to 100 (no bodily pain). The incremental change was the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at week 12 minus the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.
Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12
Time frame: Week 0 and Week 12
Each item on the Generalized Anxiety Scale (GAD) scores was scored as none (0), trivial (1), mild (2), moderate (3), or severe (4) and the sum of the 7 items calculated (range 0 to 28). The incremental change between Week 0 and Week 12 was determined for each treatment.
Incremental Change in SF36 General Health Between Baseline and Week 12
Time frame: Week 0 and Week 12
Incremental change in SF36 General Health score from baseline to week 12. The SF36 General Health score ranges from 0 (very bad General Health) to 100 (very good General Health). The incremental change was the SF36 General Health score at week 12 minus the SF36 General Health score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for SF36 General Health score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the SF36 General Health score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.

1 secondary outcome

Digit Symbol Substitution (WAIS)
Time frame: Difference between Week 0 and Week 12 (end of study)

Results and safety

Results posted to the registry on 18 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carnosine Treatment Group	18	12
Placebo Control Group	15	13

Primary outcome: Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores

Time frame: Weeks 0 and 12. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Carnosine Treatment Group n = 12	Placebo Control Group n = 13
Value	-3.8 (-11.1 to 3.5)	-2.0 (-8.4 to 4.4)

Carnosine Treatment Group: p = 0.30, t-test, 2 sided
Placebo Control Group: p = 0.40, t-test, 2 sided

Population analysed: Significant numbers of subjects dropped out of both arms of the study. The primary reason given was perceived lack of efficacy.

Primary outcome: Subjects With Improved Diarrhea Symptoms

Time frame: Weeks 0 and 12. Number. Unit: participants

Measure	Carnosine Treatment Group n = 7	Placebo Control Group n = 10
Value	5	1

Carnosine Treatment Group vs Placebo Control Group: p = 0.018, Fisher Exact

Population analysed: Participants with evaluable data at the end of the study.

Primary outcome: Incremental Change in Fatigue Score From Baseline to Week 12

Time frame: Week 0 and Week 12. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Carnosine Treatment Group n = 7	Placebo Control Group n = 12
Value	0.3 (-0.7 to 1.3)	-0.6 (-2.4 to 1.2)

Population analysed: Number of participants with evaluable data who completed the study

Primary outcome: SF36 Bodily Pain

Time frame: Week 0 and Week 12. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Carnosine Treatment Group n = 8	Placebo Control Group n = 10
Value	5.6 (-6.4 to 17.6)	-0.5 (-13.4 to 12.4)

Carnosine Treatment Group vs Placebo Control Group: p = 0.5, t-test, 2 sided

Population analysed: Number of participants with evaluable data who completed the study

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carnosine Treatment Group	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
Placebo Control Group	1 of 13 (7.7%)	0 of 13 (0%)	Not reported

Limitations and caveats (from the sponsor): Small sample sizes. No measure of changes in brain carnosine/homocarnosine/GABA. Subjective outcomes were insensitive to change. Stool consistency needed better scoring system.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12034582Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastanaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. doi: 10.1093/aje/155.11.1033.
Background: PubMed 16321154Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22. doi: 10.1186/1471-2377-5-22.
Background: PubMed 16046297Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Koppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7. doi: 10.2337/diabetes.54.8.2320.
Background: PubMed 12585724Chez MG, Buchanan CP, Aimonovitch MC, Becker M, Schaefer K, Black C, Komen J. Double-blind, placebo-controlled study of L-carnosine supplementation in children with autistic spectrum disorders. J Child Neurol. 2002 Nov;17(11):833-7. doi: 10.1177/08830738020170111501.
Results publication: PubMed 23618477Baraniuk JN, El-Amin S, Corey R, Rayhan R, Timbol C. Carnosine treatment for gulf war illness: a randomized controlled trial. Glob J Health Sci. 2013 Feb 4;5(3):69-81. doi: 10.5539/gjhs.v5n3p69.
Laboratory WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Persian Gulf Syndrome

Not yet recruiting
Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
Gulf War Syndrome
RecruitingPhase 1
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
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RecruitingPhase 2
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
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RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
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RecruitingPhase 3
Coenzyme Q10 for Gulf War Illness: A Replication Study
Gulf War Syndrome, Persian Gulf Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James N Baraniuk, MD principal investigator

Georgetown University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carnosine in people with Persian Gulf Syndrome, run by Georgetown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores (time frame: Weeks 0 and 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00810368, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.