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Arginine as an Adjuvant Treatment Against Tuberculosis

L

Linköping University (LiU)

Status

Completed

Conditions

Tuberculosis
HIV

Treatments

Dietary Supplement: Peanuts
Dietary Supplement: Daboqolo

Study type

Interventional

Funder types

Other

Identifiers

NCT00857402
HLF_20060246
ArgII

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

15 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 2 patient groups

Peanuts
Active Comparator group
Treatment:
Dietary Supplement: Peanuts
Daboqolo
Active Comparator group
Treatment:
Dietary Supplement: Daboqolo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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