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Arginine as an Adjuvant Treatment Against Tuberculosis

Primary Purpose

Tuberculosis, HIV

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Peanuts
Daboqolo
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tuberculosis focused on measuring Arginine, Nitric oxide, Peanuts, Sedimentation rate

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Gondar University, DOTS-center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Peanuts

Daboqolo

Arm Description

Outcomes

Primary Outcome Measures

Final outcome according to WHO

Secondary Outcome Measures

Change in Chest X-ray pattern from baseline to 2 months
Levels of exhaled and urinary nitric oxide
Weight gain from baseline until 2 months
Sedimentation rate
Sputum smear conversion
Reduction of cough from baseline to 2 months

Full Information

First Posted
March 5, 2009
Last Updated
March 5, 2009
Sponsor
Linkoeping University
Collaborators
University of Gondar, Kalmar County Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00857402
Brief Title
Arginine as an Adjuvant Treatment Against Tuberculosis
Official Title
Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Linkoeping University
Collaborators
University of Gondar, Kalmar County Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, HIV
Keywords
Arginine, Nitric oxide, Peanuts, Sedimentation rate

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peanuts
Arm Type
Active Comparator
Arm Title
Daboqolo
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Peanuts
Intervention Description
30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.
Intervention Type
Dietary Supplement
Intervention Name(s)
Daboqolo
Intervention Description
30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.
Primary Outcome Measure Information:
Title
Final outcome according to WHO
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Change in Chest X-ray pattern from baseline to 2 months
Time Frame
2 months
Title
Levels of exhaled and urinary nitric oxide
Time Frame
First week, week 2, week 8, and month 5
Title
Weight gain from baseline until 2 months
Time Frame
2 months
Title
Sedimentation rate
Time Frame
2 months
Title
Sputum smear conversion
Time Frame
2 months
Title
Reduction of cough from baseline to 2 months
Time Frame
1 and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Schön, MD PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sven Britton, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tommy Sundqvist, Professor
Organizational Affiliation
Linkoeping University, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Gondar University, DOTS-center
City
Gondar, Region 3, Ethiopia
State/Province
Gondar
ZIP/Postal Code
P.o. box 106
Country
Ethiopia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16242741
Citation
Schon T, Wolday D, Elias D, Melese E, Moges F, Tessema T, Stendahl O, Sundqvist T, Britton S. Kinetics of sedimentation rate, viral load and TNF-alpha in relation to HIV co-infection in tuberculosis. Trans R Soc Trop Med Hyg. 2006 May;100(5):483-8. doi: 10.1016/j.trstmh.2005.07.018. Epub 2005 Oct 20.
Results Reference
background
PubMed Identifier
12662006
Citation
Schon T, Elias D, Moges F, Melese E, Tessema T, Stendahl O, Britton S, Sundqvist T. Arginine as an adjuvant to chemotherapy improves clinical outcome in active tuberculosis. Eur Respir J. 2003 Mar;21(3):483-8. doi: 10.1183/09031936.03.00090702.
Results Reference
background
PubMed Identifier
9623681
Citation
Wang CH, Liu CY, Lin HC, Yu CT, Chung KF, Kuo HP. Increased exhaled nitric oxide in active pulmonary tuberculosis due to inducible NO synthase upregulation in alveolar macrophages. Eur Respir J. 1998 Apr;11(4):809-15. doi: 10.1183/09031936.98.11040809.
Results Reference
background
PubMed Identifier
18950489
Citation
Idh J, Westman A, Elias D, Moges F, Getachew A, Gelaw A, Sundqvist T, Forslund T, Alemu A, Ayele B, Diro E, Melese E, Wondmikun Y, Britton S, Stendahl O, Schon T. Nitric oxide production in the exhaled air of patients with pulmonary tuberculosis in relation to HIV co-infection. BMC Infect Dis. 2008 Oct 24;8:146. doi: 10.1186/1471-2334-8-146.
Results Reference
result
PubMed Identifier
21813328
Citation
Schon T, Idh J, Westman A, Elias D, Abate E, Diro E, Moges F, Kassu A, Ayele B, Forslund T, Getachew A, Britton S, Stendahl O, Sundqvist T. Effects of a food supplement rich in arginine in patients with smear positive pulmonary tuberculosis--a randomised trial. Tuberculosis (Edinb). 2011 Sep;91(5):370-7. doi: 10.1016/j.tube.2011.06.002. Epub 2011 Aug 2.
Results Reference
derived

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Arginine as an Adjuvant Treatment Against Tuberculosis

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