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Arginine as an Adjuvant Treatment Against Tuberculosis

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ClinicalTrials.gov Identifier: NCT00857402
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : March 6, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Tuberculosis HIV Dietary Supplement: Peanuts Dietary Supplement: Daboqolo

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis
Study Start Date : February 2004
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Final outcome according to WHO [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Change in Chest X-ray pattern from baseline to 2 months [ Time Frame: 2 months ]
  2. Levels of exhaled and urinary nitric oxide [ Time Frame: First week, week 2, week 8, and month 5 ]
  3. Weight gain from baseline until 2 months [ Time Frame: 2 months ]
  4. Sedimentation rate [ Time Frame: 2 months ]
  5. Sputum smear conversion [ Time Frame: 2 months ]
  6. Reduction of cough from baseline to 2 months [ Time Frame: 1 and 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: March 2009

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