L-arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)
NCT ID: NCT00677339
Last Updated: 2012-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2008-06-30
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vitamin D in Active Tuberculosis (TB) Study
NCT00788320
Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis
NCT02464683
Vitamin D Supplementation in TB Prevention
NCT02276755
Immune Reconstitution in Tuberculosis Disease
NCT01698476
Oral Vitamin D and Toll Like Receptor in Spondylitis Tuberculosis
NCT05376189
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Our specific aims are to:
1. Determine whether supplementation with L-arginine and/or vitamin D is safe, and results in more rapid improvement in clinical, mycobacterial, immunological, radiological, physiological and functional measures of treatment outcome. We will randomise patients with pulmonary TB to receive, in addition to standard TB therapy, adjunctive arginine, vitamin D and / or placebo in a randomised, double-blind factorial 2x2 design. We will relate serial measurements of plasma concentrations of L-arginine and vitamin D, and immunological responses (pulmonary NO production, T cell function and phenotype) to measures of treatment outcome \[mycobacterial (sputum smear clearance and culture conversion), physiological (spirometry), clinical (symptoms and weight), radiological (chest Xray) and functional (six-minute walk test, modified St George Respiratory Questionnaire)\].
2. Determine whether pulmonary production of NO is inversely related to disease severity at presentation. Baseline and serial measures of NO production will be related to disease severity and the magnitude and rapidity of clinical response
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Active L-arginine plus active vitamin D
L-arginine
L-arginine 6g orally daily
Vitamin D
Cholecalciferol 50000 IU once monthly orally
2
Placebo L-arginine plus active Vitamin D
Vitamin D
Cholecalciferol 50000 IU once monthly orally
Placebo L-arginine
placebo L-arginine once daily
3
Active L-arginine plus placebo vitamin D
L-arginine
L-arginine 6g orally daily
Placebo Vitamin D
placebo vitamin D orally once monthly
4
placebo L-arginine plus placebo vitamin D
Placebo L-arginine
placebo L-arginine once daily
Placebo Vitamin D
placebo vitamin D orally once monthly
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
L-arginine
L-arginine 6g orally daily
Vitamin D
Cholecalciferol 50000 IU once monthly orally
Placebo L-arginine
placebo L-arginine once daily
Placebo Vitamin D
placebo vitamin D orally once monthly
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* taking arginine or vitamin D
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
OTHER
Australian National University
OTHER
Menzies School of Health Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Anna Ralph
Global and Tropical Health
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicholas M Anstey, MBBS
Role: STUDY_DIRECTOR
Menzies School of Helath Research
Anna P Ralph, MBBS
Role: PRINCIPAL_INVESTIGATOR
Australian National University, Canberra, Australia
Franciscus Thio, MPPM
Role: PRINCIPAL_INVESTIGATOR
District Ministry of Health, Timika
Peter Morris, MBBS
Role: PRINCIPAL_INVESTIGATOR
Menzies School of Health Research, Northern Territory, Australia
Enny Kenangalem, MD
Role: PRINCIPAL_INVESTIGATOR
Papuan Community Health and Development Foundation
Jeanne R Poespoprodjo, MD
Role: PRINCIPAL_INVESTIGATOR
Mimika District Health Authority
Richard N Price, MD
Role: PRINCIPAL_INVESTIGATOR
Menzies School of Health Research
Tonia Woodberry, PhD
Role: PRINCIPAL_INVESTIGATOR
Menzies School of Health Research
Paul M Kelly, MBBS
Role: PRINCIPAL_INVESTIGATOR
Australian Capital Territory Department of Health
Emiliana Tjitra, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Sandjaja Sandjaja, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Dina B Lolong, MD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Health Research and Development
Mark Chatfield, PhD
Role: PRINCIPAL_INVESTIGATOR
National Health and Medical Research Council (Australia) Clinical Trials Centre
Ivan Bastian, MBBS
Role: PRINCIPAL_INVESTIGATOR
Institute of Medical and Veterinary Pathology, South Australia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Timika Tuberculosis Clinic and Community Hospital
Timika, Papua Province, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ralph AP, Waramori G, Pontororing GJ, Kenangalem E, Wiguna A, Tjitra E, Sandjaja, Lolong DB, Yeo TW, Chatfield MD, Soemanto RK, Bastian I, Lumb R, Maguire GP, Eisman J, Price RN, Morris PS, Kelly PM, Anstey NM. L-arginine and vitamin D adjunctive therapies in pulmonary tuberculosis: a randomised, double-blind, placebo-controlled trial. PLoS One. 2013 Aug 14;8(8):e70032. doi: 10.1371/journal.pone.0070032. eCollection 2013.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AVDAPT 1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.