NCT00857402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
Last Updated

March 6, 2009

Status Verified

March 1, 2009

Enrollment Period

2.8 years

First QC Date

March 5, 2009

Last Update Submit

March 5, 2009

Conditions

TuberculosisHIV

Keywords

ArginineNitric oxidePeanutsSedimentation rate

Outcome Measures

Primary Outcomes (1)

  • Final outcome according to WHO

    8 months

Secondary Outcomes (6)

  • Change in Chest X-ray pattern from baseline to 2 months

    2 months

  • Levels of exhaled and urinary nitric oxide

    First week, week 2, week 8, and month 5

  • Weight gain from baseline until 2 months

    2 months

  • Sedimentation rate

    2 months

  • Sputum smear conversion

    2 months

  • +1 more secondary outcomes

Study Arms (2)

Peanuts

ACTIVE COMPARATOR
Dietary Supplement: Peanuts

Daboqolo

ACTIVE COMPARATOR
Dietary Supplement: Daboqolo

Interventions

PeanutsDIETARY_SUPPLEMENT

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

Peanuts
DaboqoloDIETARY_SUPPLEMENT

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

Daboqolo

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Informed and written consent to take part in the study
  • Previously untreated and newly diagnosed smear positive Tb patients according to the WHO definitions

You may not qualify if:

  • Hospitalization
  • Pregnancy
  • Known allergy against peanuts
  • Chronic or acute disease other than tuberculosis/HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gondar University, DOTS-center

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

Location

Related Publications (5)

  • 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.

    PMID: 16242741BACKGROUND

  • 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.

    PMID: 12662006BACKGROUND

  • 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.

    PMID: 9623681BACKGROUND

  • 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.

    PMID: 18950489RESULT

  • 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.

    PMID: 21813328DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Thomas Schön, MD PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

  • Sven Britton, Professor

    Karolinska Institutet

    STUDY DIRECTOR

  • Tommy Sundqvist, Professor

    Linkoeping University, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

February 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

March 6, 2009

Record last verified: 2009-03

Locations

ET(1)