Tuberculosis, HIV
Conditions
Keywords
Arginine, Nitric oxide, Peanuts, Sedimentation rate
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPeanuts
30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.
DIETARY_SUPPLEMENTDaboqolo
30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.
Sponsors
University of Gondar
Kalmar County Hospital
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Final outcome according to WHO | 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Levels of exhaled and urinary nitric oxide | First week, week 2, week 8, and month 5 |
| Weight gain from baseline until 2 months | 2 months |
| Change in Chest X-ray pattern from baseline to 2 months | 2 months |
| Sputum smear conversion | 2 months |
| Reduction of cough from baseline to 2 months | 1 and 2 months |
| Sedimentation rate | 2 months |
Countries
Ethiopia
Outcome results
None listed