Arginine as an Adjuvant Treatment Against Tuberculosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tuberculosis, HIV

Intervention / Treatment
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* Dietary Supplement: Peanuts
* Dietary Supplement: Daboqolo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peanuts<br> | Dietary Supplement: Peanuts<br>* 30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.<br>|
| Active Comparator: Daboqolo<br> | Dietary Supplement: Daboqolo<br>* 30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final outcome according to WHO |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Chest X-ray pattern from baseline to 2 months |  | 2 months | 
| 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 | 
| Sedimentation rate |  | 2 months | 
| Sputum smear conversion |  | 2 months | 
| Reduction of cough from baseline to 2 months |  | 1 and 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arginine, Nitric oxide, Peanuts, Sedimentation rate