TuberculosisNCT00857402
Arginine as an Adjuvant Treatment Against Tuberculosis
A study testing Peanuts and Daboqolo in people with Tuberculosis and HIV, run by Linkoeping University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Tuberculosis, HIV
- What is being tested?
- Peanuts and Daboqolo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEthiopia
- Study dates
- Feb 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed and written consent to take part in the study
- Previously untreated and newly diagnosed smear positive Tb patients according to the WHO definitions
Who cannot join
- Hospitalization
- Pregnancy
- Known allergy against peanuts
- Chronic or acute disease other than tuberculosis/HIV
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Gondar University, DOTS-center
Gondar, Region 3, Ethiopia, Gondar, P.o. box 106
About this study
Official title: 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.
Read the 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.
- Conditions
- Tuberculosis, HIV
- Being tested
- Peanuts, Daboqolo
- Keywords
- Arginine, Nitric oxide, Peanuts, Sedimentation rate
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeanutsDietary supplement
30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.
DaboqoloDietary supplement
30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.
| Study group | Role | What they receive |
|---|---|---|
| Peanuts | Active comparator | Not described Receives: Dietary Supplement: Peanuts |
| Daboqolo | Active comparator | Not described Receives: Dietary Supplement: Daboqolo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final outcome according to WHO
Measured: 8 months
Secondary outcomes (6)
Change in Chest X-ray pattern from baseline to 2 months
Measured: 2 months
Levels of exhaled and urinary nitric oxide
Measured: First week, week 2, week 8, and month 5
Weight gain from baseline until 2 months
Measured: 2 months
Sedimentation rate
Measured: 2 months
Sputum smear conversion
Measured: 2 months
Reduction of cough from baseline to 2 months
Measured: 1 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startFeb 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- University of Gondar, Kalmar County Hospital
- Investigators
- Thomas Schön, MD PhD, Principal investigator, Linkoeping UniversitySven Britton, Professor, Study director, Karolinska InstitutetTommy Sundqvist, Professor, Study chair, Linkoeping University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857402
- Sponsor's protocol ID
- ArgII
- Other IDs
- HLF_20060246
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2009
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16242741Schon 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.
PubMed 12662006Wang 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.
PubMed 9623681Idh 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.
PubMed 18950489Schon 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.
PubMed 21813328
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis
- ClinicalTrials.gov ID
- NCT00857402
- Acronym / sponsor ID
- ArgII
- Conditions
- Tuberculosis, HIV
- Keywords
- Arginine, Nitric oxide, Peanuts, Sedimentation rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- University of Gondar, Kalmar County Hospital
- Study start
- Feb 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanuts | Active comparator | Dietary Supplement: Peanuts |
| Daboqolo | Active comparator | Dietary Supplement: Daboqolo |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Informed and written consent to take part in the study
- Previously untreated and newly diagnosed smear positive Tb patients according to the WHO definitions
Key exclusion criteria (4 listed)
- Hospitalization
- Pregnancy
- Known allergy against peanuts
- Chronic or acute disease other than tuberculosis/HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanuts30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine. | Dietary supplement | Peanuts |
| Daboqolo30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine. | Dietary supplement | Daboqolo |
Primary outcome
Final outcome according to WHO
Time frame: 8 months
6 secondary outcomes
Change in Chest X-ray pattern from baseline to 2 months
Time frame: 2 months
Levels of exhaled and urinary nitric oxide
Time frame: First week, week 2, week 8, and month 5
Weight gain from baseline until 2 months
Time frame: 2 months
Sedimentation rate
Time frame: 2 months
Sputum smear conversion
Time frame: 2 months
Reduction of cough from baseline to 2 months
Time frame: 1 and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
- Background: PubMed 16242741Schon 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.
- Background: PubMed 12662006Schon 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.
- Background: PubMed 9623681Wang 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 publication: PubMed 18950489Idh 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.
- Derived from this study: PubMed 21813328Schon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Schön, MD PhD principal investigator
Linkoeping University
Sven Britton, Professor study director
Karolinska Institutet
Tommy Sundqvist, Professor study chair
Linkoeping University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanuts and Daboqolo in people with Tuberculosis and HIV, run by Linkoeping University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final outcome according to WHO (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00857402, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2009.