Arginine as an Adjuvant Treatment Against Tuberculosis

March 5, 2009 updated by: Linkoeping University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Gondar
      • Gondar, Region 3, Ethiopia, Gondar, Ethiopia, P.o. box 106
        • Gondar University, DOTS-center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Final outcome according to WHO
Time Frame: 8 months
8 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Collaborators

Kalmar County Hospital
University of Gondar

Investigators

  • Study Director: Sven Britton, Professor, Karolinska Institutet
  • Study Chair: Tommy Sundqvist, Professor, Linkoeping University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (ESTIMATE)

March 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2009

Last Update Submitted That Met QC Criteria

March 5, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ArgII
  • HLF_20060246

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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