Arginine as an Adjuvant Treatment Against Tuberculosis

This study has been completed.
Sponsor:
Collaborators:
University of Gondar
Kalmar County Hospital
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT00857402
First received: March 5, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 5, 2009
March 5, 2009
February 2004
December 2006   (final data collection date for primary outcome measure)
Final outcome according to WHO [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Change in Chest X-ray pattern from baseline to 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Levels of exhaled and urinary nitric oxide [ Time Frame: First week, week 2, week 8, and month 5 ] [ Designated as safety issue: No ]
  • Weight gain from baseline until 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Sedimentation rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Sputum smear conversion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Reduction of cough from baseline to 2 months [ Time Frame: 1 and 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Arginine as an Adjuvant Treatment Against Tuberculosis
Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
  • Tuberculosis
  • HIV
  • 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.
  • Active Comparator: Peanuts
    Intervention: Dietary Supplement: Peanuts
  • Active Comparator: Daboqolo
    Intervention: Dietary Supplement: Daboqolo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
15 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
NCT00857402
ArgII, HLF_20060246
No
Thomas Schön, Linkoeping University
Linkoeping University
  • University of Gondar
  • Kalmar County Hospital
Principal Investigator: Thomas Schön, MD PhD Linkoeping University
Study Director: Sven Britton, Professor Karolinska Institutet
Study Chair: Tommy Sundqvist, Professor Linkoeping University, Sweden
Linkoeping University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP