Trial | NCT00857402  Report issue

Title

Arginine as an Adjuvant Treatment Against Tuberculosis
Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    180
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 Started
Feb 29
2004
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Mar 06
2009
Estimate

Dietary Supplement Peanuts

30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.

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.

Peanuts Active Comparator

Daboqolo Active Comparator

Criteria 

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
No Results Posted