Arginine as an Adjuvant Treatment Against Tuberculosis
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|ClinicalTrials.gov Identifier: NCT00857402|
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : March 6, 2009
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis HIV||Dietary Supplement: Peanuts Dietary Supplement: Daboqolo||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
|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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|