Arginine as an Adjuvant Treatment Against Tuberculosis

Not Applicable

Completed

• Conditions: HIV; Tuberculosis
• Interventions: Dietary Supplement: Peanuts; Dietary Supplement: Daboqolo

• Registration Number: NCT00857402
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Last Update Submitted: 2009-03-05
• Study First Posted: 2009-03-06
• Last Update Posted: 2009-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peanuts	Peanuts	-
Daboqolo	Daboqolo	-

Primary Outcome Measures

Name	Time	Method
Final outcome according to WHO	8 months

Secondary Outcome Measures

Name	Time	Method
Change in Chest X-ray pattern from baseline to 2 months	2 months
Weight gain from baseline until 2 months	2 months
Sedimentation rate	2 months
Reduction of cough from baseline to 2 months	1 and 2 months
Levels of exhaled and urinary nitric oxide	First week, week 2, week 8, and month 5
Sputum smear conversion	2 months

Trial Locations

Locations (1)

Gondar University, DOTS-center; 🇪🇹 Gondar, Region 3, Ethiopia, Gondar, Ethiopia