Status:
COMPLETED
L-arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Australian National University
Conditions:
Smear Positive Pulmonary Tuberculosis
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether adjunctive L-arginine and vitamin D can improve response to standard short course TB therapy in people with newly diagnosed pulmonary TB.
Detailed Description
The two major pathways proposed to mediate macrophage mycobacterial killing in humans are the arginine-nitric oxide and Vitamin D-1,25 dihydroxyvitamin D pathways. Our aim is to determine if the key i...
Eligibility Criteria
Inclusion
- Adults \>15 years with sputum smear positive pulmonary TB
- New cases only
- Agree to continue treatment in Timika for the full six month course of treatment -Not pregnant
- Consent to enroll in the study.
Exclusion
- hypercalcaemia (ionized calcium \>1.32 mmol/L) identified at baseline
- taking arginine or vitamin D
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00677339
Start Date
June 1 2008
End Date
May 1 2010
Last Update
January 18 2012
Active Locations (1)
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1
Timika Tuberculosis Clinic and Community Hospital
Timika, Papua Province, Indonesia