HIV Clinical Trial
Official title:
Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Informed and written consent to take part in the study - Previously untreated and newly diagnosed smear positive Tb patients according to the WHO definitions Exclusion Criteria: - Hospitalization - Pregnancy - Known allergy against peanuts - Chronic or acute disease other than tuberculosis/HIV |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Ethiopia | Gondar University, DOTS-center | Gondar, Region 3, Ethiopia | Gondar |
Lead Sponsor | Collaborator |
---|---|
Linkoeping University | Kalmar County Hospital, University of Gondar |
Ethiopia,
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, Schön T. Nitric oxide production in the exhaled air of patients with pulmonary tuberculosis in relati — View Citation
Schön 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. — View Citation
Schön 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. Epub 2005 Oct 20. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Final outcome according to WHO | 8 months | No | |
Secondary | Change in Chest X-ray pattern from baseline to 2 months | 2 months | No | |
Secondary | Levels of exhaled and urinary nitric oxide | First week, week 2, week 8, and month 5 | No | |
Secondary | Weight gain from baseline until 2 months | 2 months | No | |
Secondary | Sedimentation rate | 2 months | No | |
Secondary | Sputum smear conversion | 2 months | No | |
Secondary | Reduction of cough from baseline to 2 months | 1 and 2 months | No |
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