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
  Purpose

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.


Condition Intervention
Tuberculosis
HIV
Dietary Supplement: Peanuts
Dietary Supplement: Daboqolo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Final outcome according to WHO [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 180
Study Start Date: February 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Peanuts Dietary Supplement: Peanuts
30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.
Active Comparator: Daboqolo 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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857402

Locations
Ethiopia
Gondar University, DOTS-center
Gondar, Region 3, Ethiopia, Gondar, Ethiopia, P.o. box 106
Sponsors and Collaborators
Linkoeping University
University of Gondar
Kalmar County Hospital
Investigators
Principal Investigator: Thomas Schön, MD PhD Linkoeping University
Study Director: Sven Britton, Professor Karolinska Institutet
Study Chair: Tommy Sundqvist, Professor Linkoeping University, Sweden
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Schön, Linkoeping University
ClinicalTrials.gov Identifier: NCT00857402     History of Changes
Other Study ID Numbers: ArgII, HLF_20060246
Study First Received: March 5, 2009
Last Updated: March 5, 2009
Health Authority: Ethiopia: Ethiopia Science and Technology Commission
Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Arginine
Nitric oxide
Peanuts
Sedimentation rate

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 29, 2014