Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT00810368
Status:
COMPLETED
Last Update Posted:
2019-06-28
First Post:
2008-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018923', 'term': 'Persian Gulf Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D018777', 'term': 'Multiple Chemical Sensitivity'}], 'ancestors': [{'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000067398', 'term': 'War-Related Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D018876', 'term': 'Environmental Illness'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007280', 'term': 'Disorders of Environmental Origin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002336', 'term': 'Carnosine'}], 'ancestors': [{'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'baraniuklab@gmail.com', 'phone': '202-687-8231', 'title': 'Dr. James N Baraniuk', 'organization': 'Georgetown University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample sizes. No measure of changes in brain carnosine/homocarnosine/GABA.\n\nSubjective outcomes were insensitive to change. Stool consistency needed better scoring system.'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Carnosine Treatment Group', 'description': '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.', 'otherNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Control Group', 'description': '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.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Costochondritis', 'notes': 'A subject with chronic rib pain and tenderness of costochondritis was sent by his primary care physician to a cardiologist. No cardiac pathology was found. This was considered Grade 1, not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypergammaglobulinemia', 'notes': 'One subject had elevated gamma globulins at week 6 (grade 2 adverse event, not related to study drug). The subjects dropped out of the study and was lost to follow-up.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Elevated CRP Levels', 'notes': 'At week 6, one subject showed elevated CRP levels (Grade 1, not related). As per protocol, study drug was discontinued for 2 weeks. Hepatitis A, B, and C serologies were negative, and tests normalized. Study drug was restarted with no sequelae.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carnosine Treatment Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo Control Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'groupId': 'OG000', 'lowerLimit': '-11.1', 'upperLimit': '3.5'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-8.4', 'upperLimit': '4.4'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': "2-tailed paired Student's t-tests between Week 0 and Week 12 responses (above) were anticipated to show significant benefits with carnosine treatment but no change with placebo. There were no corrections for multiple comparisons in the reported data.", 'groupDescription': 'Description of Power Calculation: The planned sample size completing each arm was based on individual incremental improvements in the primary outcomes of : A) CFS Severity Scores (Baraniuk et al., Annals Allergy Astma Immunol, 1998), B) Instantaneous Fatigue (Kim et al. Journal of Rehab Res Dev, 2010), and C) increased accuracy of 4/35 letters for 2 back working memory task (Owen, Human Brain Mapping, 2005).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Paired t-test'}, {'pValue': '0.40', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0 and 12', 'description': '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.\n\nIndividuals 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Significant numbers of subjects dropped out of both arms of the study. The primary reason given was perceived lack of efficacy.'}, {'type': 'PRIMARY', 'title': 'Subjects With Improved Diarrhea Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carnosine Treatment Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo Control Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': "Using Fisher's Exact Test, we determined whether there was a significant difference in the number of participants complaining of IBS symptoms.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "2 by 2 Fisher's Exact Test"}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0 and 12', 'description': 'Patients were given questionnaires assessing common symptom complaints of diarrhea.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with evaluable data at the end of the study.'}, {'type': 'SECONDARY', 'title': 'Digit Symbol Substitution (WAIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carnosine Treatment Group', 'description': 'Carnosine treatment group\n\nCarnosine: 500mg Carnosine x2 daily'}, {'id': 'OG001', 'title': 'Placebo Control Group', 'description': 'Placebo control group\n\nPlacebo: Microcrystalline cellulose placebo tablets x2 daily'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '15.6'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '6.3'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.60', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Difference between Week 0 and Week 12 (end of study)', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '2 carnosine subjects had incomplete data.'}, {'type': 'PRIMARY', 'title': 'Incremental Change in Fatigue Score From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carnosine Treatment Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo Control Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '1.3'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '1.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 12', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with evaluable data who completed the study'}, {'type': 'PRIMARY', 'title': 'SF36 Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carnosine Treatment Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo Control Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '-6.4', 'upperLimit': '17.6'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-13.4', 'upperLimit': '12.4'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 12', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with evaluable data who completed the study'}, {'type': 'PRIMARY', 'title': 'Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carnosine Treatment Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo Control Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '2.7'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '2.3'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 12', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with evaluable data who completed the study'}, {'type': 'PRIMARY', 'title': 'Incremental Change in SF36 General Health Between Baseline and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carnosine Treatment Group', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo Control Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-13.3', 'upperLimit': '14.3'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '17.3'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 12', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with evaluable data who completed the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carnosine Treatment Group', 'description': '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.'}, {'id': 'FG001', 'title': 'Placebo Control Group', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Carnosine Treatment Group', 'description': '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.'}, {'id': 'BG001', 'title': 'Placebo Control Group', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '47.2', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '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.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2008-12-17', 'resultsFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2008-12-17', 'lastUpdatePostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-08', 'studyFirstPostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores', 'timeFrame': 'Weeks 0 and 12', 'description': '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.\n\nIndividuals 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.'}, {'measure': 'Subjects With Improved Diarrhea Symptoms', 'timeFrame': 'Weeks 0 and 12', 'description': 'Patients were given questionnaires assessing common symptom complaints of diarrhea.'}, {'measure': 'Incremental Change in Fatigue Score From Baseline to Week 12', 'timeFrame': 'Week 0 and Week 12', 'description': '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.'}, {'measure': 'SF36 Bodily Pain', 'timeFrame': 'Week 0 and Week 12', 'description': '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.'}, {'measure': 'Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12', 'timeFrame': 'Week 0 and Week 12', 'description': '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.'}, {'measure': 'Incremental Change in SF36 General Health Between Baseline and Week 12', 'timeFrame': 'Week 0 and Week 12', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Digit Symbol Substitution (WAIS)', 'timeFrame': 'Difference between Week 0 and Week 12 (end of study)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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'], 'conditions': ['Persian Gulf Syndrome']}, 'referencesModule': {'references': [{'pmid': '12034582', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16321154', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16046297', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12585724', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23618477', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www9.georgetown.edu/faculty/baraniuj/Site/Welcome.html', 'label': 'Laboratory Website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDrug: 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.\n\nHypothesis: Carnosine supplementation for 12 weeks by mouth in Gulf War Illness subjects would improve cognitive and other outcomes compared to placebo treatment.\n\nSubjects: Gulf War Illness subjects met 1996 Fukuda criteria for Chronic Multisymptom Illness.\n\nDesign: 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).\n\nAn improvement on accuracy on the 2-back working memory task between 0 and 12 weeks was the primary outcome.\n\nOther evaluations were secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '34 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:\n\n * Persian Gulf waters and adjacent land areas,\n * Other global locations, or,\n * U.S. only. 1990-1991 enlistment status:\n * Active duty\n * National Guard\n * Reserves\n\nExclusion Criteria:\n\n* HIV/AIDS\n* Pregnant Women\n* Active Duty Military Personnel\n* Children\n* Incarceration'}, 'identificationModule': {'nctId': 'NCT00810368', 'briefTitle': 'Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Carnosine Versus Placebo Treatment Study in Gulf War Illness (GWI)', 'orgStudyIdInfo': {'id': '2008-068'}, 'secondaryIdInfos': [{'id': 'USAMRMC PR# W91ZSQ-7149-N602', 'type': 'OTHER_GRANT', 'domain': 'CDMRP, DoD'}, {'id': 'HRPO Log No. A-14542.2', 'type': 'OTHER', 'domain': 'Human Research Protection Office protocol number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carnosine treatment group', 'description': 'Carnosine treatment group', 'interventionNames': ['Drug: Carnosine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo control group', 'description': 'Placebo control group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Carnosine', 'type': 'DRUG', 'otherNames': ['Pathway Carnosine supplied by Village Green Apothecary'], 'description': '500mg Carnosine x2 daily', 'armGroupLabels': ['Carnosine treatment group']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Village Green Apothecary'], 'description': 'Microcrystalline cellulose placebo tablets x2 daily', 'armGroupLabels': ['Placebo control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'James N Baraniuk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'James Baraniuk, MD', 'investigatorAffiliation': 'Georgetown University'}}}}