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.
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. Previous 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
180
Gondar University, DOTS-center
Gondar, Region 3, Ethiopia, Gondar, Ethiopia
Final outcome according to WHO
Time frame: 8 months
Change in Chest X-ray pattern from baseline to 2 months
Time frame: 2 months
Levels of exhaled and urinary nitric oxide
Time frame: First week, week 2, week 8, and month 5
Weight gain from baseline until 2 months
Time frame: 2 months
Sedimentation rate
Time frame: 2 months
Sputum smear conversion
Time frame: 2 months
Reduction of cough from baseline to 2 months
Time frame: 1 and 2 months
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