Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT00857402
Status:
COMPLETED
Last Update Posted:
2009-03-06
First Post:
2009-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arginine as an Adjuvant Treatment Against Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-05', 'studyFirstSubmitDate': '2009-03-05', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Final outcome according to WHO', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'Change in Chest X-ray pattern from baseline to 2 months', 'timeFrame': '2 months'}, {'measure': 'Levels of exhaled and urinary nitric oxide', 'timeFrame': 'First week, week 2, week 8, and month 5'}, {'measure': 'Weight gain from baseline until 2 months', 'timeFrame': '2 months'}, {'measure': 'Sedimentation rate', 'timeFrame': '2 months'}, {'measure': 'Sputum smear conversion', 'timeFrame': '2 months'}, {'measure': 'Reduction of cough from baseline to 2 months', 'timeFrame': '1 and 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arginine', 'Nitric oxide', 'Peanuts', 'Sedimentation rate'], 'conditions': ['Tuberculosis', 'HIV']}, 'referencesModule': {'references': [{'pmid': '16242741', 'type': 'BACKGROUND', 'citation': 'Schon T, Wolday D, Elias D, Melese E, Moges F, Tessema T, Stendahl O, Sundqvist T, Britton S. Kinetics of sedimentation rate, viral load and TNF-alpha in relation to HIV co-infection in tuberculosis. Trans R Soc Trop Med Hyg. 2006 May;100(5):483-8. doi: 10.1016/j.trstmh.2005.07.018. Epub 2005 Oct 20.'}, {'pmid': '12662006', 'type': 'BACKGROUND', 'citation': 'Schon T, Elias D, Moges F, Melese E, Tessema T, Stendahl O, Britton S, Sundqvist T. Arginine as an adjuvant to chemotherapy improves clinical outcome in active tuberculosis. Eur Respir J. 2003 Mar;21(3):483-8. doi: 10.1183/09031936.03.00090702.'}, {'pmid': '9623681', 'type': 'BACKGROUND', 'citation': 'Wang CH, Liu CY, Lin HC, Yu CT, Chung KF, Kuo HP. Increased exhaled nitric oxide in active pulmonary tuberculosis due to inducible NO synthase upregulation in alveolar macrophages. Eur Respir J. 1998 Apr;11(4):809-15. doi: 10.1183/09031936.98.11040809.'}, {'pmid': '18950489', 'type': 'RESULT', 'citation': 'Idh J, Westman A, Elias D, Moges F, Getachew A, Gelaw A, Sundqvist T, Forslund T, Alemu A, Ayele B, Diro E, Melese E, Wondmikun Y, Britton S, Stendahl O, Schon T. Nitric oxide production in the exhaled air of patients with pulmonary tuberculosis in relation to HIV co-infection. BMC Infect Dis. 2008 Oct 24;8:146. doi: 10.1186/1471-2334-8-146.'}, {'pmid': '21813328', 'type': 'DERIVED', 'citation': 'Schon T, Idh J, Westman A, Elias D, Abate E, Diro E, Moges F, Kassu A, Ayele B, Forslund T, Getachew A, Britton S, Stendahl O, Sundqvist T. Effects of a food supplement rich in arginine in patients with smear positive pulmonary tuberculosis--a randomised trial. Tuberculosis (Edinb). 2011 Sep;91(5):370-7. doi: 10.1016/j.tube.2011.06.002. Epub 2011 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate if adjuvant treatment with arginine (the substrate for nitric oxide production) rich food supplements could improve clinical outcome in patients with smear positive tuberculosis by affecting nitric oxide production.', 'detailedDescription': 'Tuberculosis (TB) is disease of increased global public health importance. Because of emerging multi drug resistance and the long treatment duration there is a need to optimize the current chemotherapy. Host immunity is important in determining the susceptibility and outcome of disease as could be exemplified by co infection with HIV which dramatically increases the risk to develop TB.\n\nPrevious results from our group and others show that nitric oxide produced by activated macrophages from arginine might be important to control the disease. However, the relative importance of nitric oxide in human TB has been debated. In a previous study in Gondar, Ethiopia, we observed an effect of adjuvant treatment with arginine capsules on sputum smear conversion and reduction of cough. In this study we wanted to test the hypothesis based on previous observations that an arginine rich food supplementation might enhance clinical improvement in patients with smear positive tuberculosis and if this effect could be due to increased nitric oxide production.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed and written consent to take part in the study\n* Previously untreated and newly diagnosed smear positive Tb patients according to the WHO definitions\n\nExclusion Criteria:\n\n* Hospitalization\n* Pregnancy\n* Known allergy against peanuts\n* Chronic or acute disease other than tuberculosis/HIV'}, 'identificationModule': {'nctId': 'NCT00857402', 'briefTitle': 'Arginine as an Adjuvant Treatment Against Tuberculosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis', 'orgStudyIdInfo': {'id': 'ArgII'}, 'secondaryIdInfos': [{'id': 'HLF_20060246'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peanuts', 'interventionNames': ['Dietary Supplement: Peanuts']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Daboqolo', 'interventionNames': ['Dietary Supplement: Daboqolo']}], 'interventions': [{'name': 'Peanuts', 'type': 'DIETARY_SUPPLEMENT', 'description': '30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.', 'armGroupLabels': ['Peanuts']}, {'name': 'Daboqolo', 'type': 'DIETARY_SUPPLEMENT', 'description': '30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.', 'armGroupLabels': ['Daboqolo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P.o. box 106', 'city': 'Gondar, Region 3, Ethiopia', 'state': 'Gondar', 'country': 'Ethiopia', 'facility': 'Gondar University, DOTS-center', 'geoPoint': {'lat': 12.6, 'lon': 37.46667}}], 'overallOfficials': [{'name': 'Thomas Schön, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}, {'name': 'Sven Britton, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Tommy Sundqvist, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Linkoeping University, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Gondar', 'class': 'OTHER'}, {'name': 'Kalmar County Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Thomas Schön', 'oldOrganization': 'Linkoeping University'}}}}