Arginine as an Adjuvant Treatment Against Tuberculosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
|Official Title:||Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis|
- Final outcome according to WHO [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- Change in Chest X-ray pattern from baseline to 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Levels of exhaled and urinary nitric oxide [ Time Frame: First week, week 2, week 8, and month 5 ] [ Designated as safety issue: No ]
- Weight gain from baseline until 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Sedimentation rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Sputum smear conversion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Reduction of cough from baseline to 2 months [ Time Frame: 1 and 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
|Active Comparator: Peanuts||
Dietary Supplement: Peanuts
30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.
|Active Comparator: Daboqolo||
Dietary Supplement: Daboqolo
30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857402
|Gondar University, DOTS-center|
|Gondar, Region 3, Ethiopia, Gondar, Ethiopia, P.o. box 106|
|Principal Investigator:||Thomas Schön, MD PhD||Linkoeping University|
|Study Director:||Sven Britton, Professor||Karolinska Institutet|
|Study Chair:||Tommy Sundqvist, Professor||Linkoeping University, Sweden|