Arginine as an Adjuvant Treatment Against Tuberculosis

HIV Clinical Trial

Official title:

Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857402
• Other study ID #: ArgII
• Secondary ID: HLF_20060246
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: March 5, 2009
• Start date: February 2004
• Est. completion date: December 2006

Study information

• Verified date: March 2009
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ethiopia Science and Technology CommissionSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV
• Tuberculosis

Intervention

Dietary Supplement:
• Peanuts
30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.
• Daboqolo
30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.

Locations

Country	Name	City	State
Ethiopia	Gondar University, DOTS-center	Gondar, Region 3, Ethiopia	Gondar

Sponsors (3)

Lead Sponsor	Collaborator
Linkoeping University	Kalmar County Hospital, University of Gondar

Country where clinical trial is conducted

Ethiopia, 

References & Publications (4)

Idh J, Westman A, Elias D, Moges F, Getachew A, Gelaw A, Sundqvist T, Forslund T, Alemu A, Ayele B, Diro E, Melese E, Wondmikun Y, Britton S, Stendahl O, Schön T. Nitric oxide production in the exhaled air of patients with pulmonary tuberculosis in relati — View Citation

Schön T, Elias D, Moges F, Melese E, Tessema T, Stendahl O, Britton S, Sundqvist T. Arginine as an adjuvant to chemotherapy improves clinical outcome in active tuberculosis. Eur Respir J. 2003 Mar;21(3):483-8. — View Citation

Schön T, Wolday D, Elias D, Melese E, Moges F, Tessema T, Stendahl O, Sundqvist T, Britton S. Kinetics of sedimentation rate, viral load and TNF-alpha in relation to HIV co-infection in tuberculosis. Trans R Soc Trop Med Hyg. 2006 May;100(5):483-8. Epub 2005 Oct 20. — View Citation

Wang CH, Liu CY, Lin HC, Yu CT, Chung KF, Kuo HP. Increased exhaled nitric oxide in active pulmonary tuberculosis due to inducible NO synthase upregulation in alveolar macrophages. Eur Respir J. 1998 Apr;11(4):809-15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final outcome according to WHO		8 months	No
Secondary	Change in Chest X-ray pattern from baseline to 2 months		2 months	No
Secondary	Levels of exhaled and urinary nitric oxide		First week, week 2, week 8, and month 5	No
Secondary	Weight gain from baseline until 2 months		2 months	No
Secondary	Sedimentation rate		2 months	No
Secondary	Sputum smear conversion		2 months	No
Secondary	Reduction of cough from baseline to 2 months		1 and 2 months	No