L-arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)

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.

Conditions

• Smear Positive Pulmonary Tuberculosis

Interventions

DRUG

L-arginine

L-arginine 6g orally daily

DRUG

Vitamin D

Cholecalciferol 50000 IU once monthly orally

DRUG

Placebo L-arginine

placebo L-arginine once daily

DRUG

Placebo Vitamin D

placebo vitamin D orally once monthly

Sponsors & Collaborators

• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

  collaborator OTHER

• Australian National University

  collaborator OTHER

• Menzies School of Health Research

  lead OTHER

Principal Investigators

• Nicholas M Anstey, MBBS · Menzies School of Helath Research

• Anna P Ralph, MBBS · Australian National University, Canberra, Australia

• Franciscus Thio, MPPM · District Ministry of Health, Timika

• Peter Morris, MBBS · Menzies School of Health Research, Northern Territory, Australia

• Enny Kenangalem, MD · Papuan Community Health and Development Foundation

• Jeanne R Poespoprodjo, MD · Mimika District Health Authority

• Richard N Price, MD · Menzies School of Health Research

• Tonia Woodberry, PhD · Menzies School of Health Research

• Paul M Kelly, MBBS · Australian Capital Territory Department of Health

• Emiliana Tjitra, MD, PhD · National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

• Sandjaja Sandjaja, PhD · National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

• Dina B Lolong, MD · National Institute of Health Research and Development

• Mark Chatfield, PhD · National Health and Medical Research Council (Australia) Clinical Trials Centre

• Ivan Bastian, MBBS · Institute of Medical and Veterinary Pathology, South Australia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2010-02-28

Completion

2010-05-31

Countries

• Indonesia

Study Locations