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Completed

NCT Number: NCT00857402

Arginine 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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections HIV Infections Mycobacterium Infections

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gondar University, DOTS-center

Gondar, Region 3, Ethiopia, Gondar, P.o. box 106, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peanuts

Dietary Supplement

30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.

Daboqolo

Dietary Supplement

30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.

Primary outcomes

  1. Final outcome according to WHO

    Time frame: 8 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Kalmar County Hospital
  • University of Gondar

Registry information

Official study title

Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Mar 6, 2009
Registry last updated
Mar 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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