Trial | NCT00677339  Report issue

Title

L-arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)
Phase 3 Trial of Oral L-arginine and / or Vitamin D as Adjunctive Therapies in Pulmonary Tuberculosis in Papua Province, Indonesia.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 arginine ...

  • Study Participants

    200
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.
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 immunomodulatory agents L-arginine and vitamin D can improve the rapidity and magnitude of the microbiological and clinical response in pulmonary TB. We will test the following hypotheses in newly-diagnosed TB patients in Timika, Papua, Indonesia:

Our specific aims are to:

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)].
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
Study Started
Jun 30
2008
Primary Completion
Feb 28
2010
Study Completion
May 31
2010
Last Update
Jan 18
2012
Estimate

Drug L-arginine

L-arginine 6g orally daily

  • Other names: Argimax

Drug Vitamin D

Cholecalciferol 50000 IU once monthly orally

  • Other names: Calciferol Strong

Drug Placebo L-arginine

placebo L-arginine once daily

Drug Placebo Vitamin D

placebo vitamin D orally once monthly

1 Active Comparator

Active L-arginine plus active vitamin D

2 Active Comparator

Placebo L-arginine plus active Vitamin D

3 Active Comparator

Active L-arginine plus placebo vitamin D

4 Placebo Comparator

placebo L-arginine plus placebo vitamin D

Criteria 

Inclusion Criteria:

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 Criteria:

hypercalcaemia (ionized calcium >1.32 mmol/L) identified at baseline
taking arginine or vitamin D
No Results Posted