---
title: L-arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)
nct_id: NCT00677339
overall_status: COMPLETED
phase: PHASE3
sponsor: Menzies School of Health Research
study_type: INTERVENTIONAL
primary_condition: Smear Positive Pulmonary Tuberculosis
countries: Indonesia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00677339.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00677339"
ct_last_update_post_date: 2012-01-18
last_seen_at: "2026-05-12T07:14:04.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# L-arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)

**Official Title:** Phase 3 Trial of Oral L-arginine and / or Vitamin D as Adjunctive Therapies in Pulmonary Tuberculosis in Papua Province, Indonesia.

**NCT ID:** [NCT00677339](https://clinicaltrials.gov/study/NCT00677339)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Menzies School of Health Research
- **Collaborators:** National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, Australian National University
- **Conditions:** Smear Positive Pulmonary Tuberculosis
- **Start Date:** 2008-06
- **Completion Date:** 2010-05
- **CT.gov Last Update:** 2012-01-18

## 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 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:

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

## Eligibility

- **Minimum age:** 15 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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

## Interventions

- **L-arginine** (DRUG) — L-arginine 6g orally daily
- **Vitamin D** (DRUG) — Cholecalciferol 50000 IU once monthly orally
- **Placebo L-arginine** (DRUG) — placebo L-arginine once daily
- **Placebo Vitamin D** (DRUG) — placebo vitamin D orally once monthly

## Primary Outcomes

- **Proportion of pulmonary TB patients who are culture negative at 1 month** _(time frame: 1 month)_
- **Difference in improvement in composite clinical endpoint comprising weight, cough clearance and FEV1 at 2 months.** _(time frame: 2 months)_

## Secondary Outcomes

- **Change in plasma L-arginine concentration** _(time frame: week 0, 2, 4, 8, 24)_
- **Change in plasma 25(OH)D3 concentration** _(time frame: week 0, 2, 4, 8, 24)_
- **Death, clinical failure and default independently, and 'death or clinical failure or default'.** _(time frame: week 24)_
- **Hypercalcaemia** _(time frame: week 0, 2, 4, 8, 24)_
- **Gastrointestinal side effects** _(time frame: weekly to week 8 then at week 24)_
- **Sputum smear conversion time** _(time frame: weekly to week 8 then at week 24)_
- **Radiological improvement (percentage lung involvement on CXR at 2 months).** _(time frame: week 0, 2, 4, 8, 24)_
- **Cough clearance** _(time frame: weekly to week 8 then at week 24)_
- **Difference in improvement in percent predicted FEV1 at 2 and 6 months.** _(time frame: weeks 0, 4, 8, 24)_
- **Weight gain** _(time frame: weekly to week 8 then at week 24)_
- **Immunological improvement (exhaled NO)** _(time frame: week 0, 2, 4, 8, 24)_
- **Immunological improvement (T cell CD3ζ expression and T cell function)** _(time frame: week 0, 2, 4, 24)_
- **Functional improvement measured using six minute walk test** _(time frame: week 0, 4, 8, 24)_
- **Quality of life assessment using modified St George Respiratory Questionnaire.** _(time frame: weeks 0, 4, 8, 24)_
- **Primary end points stratified by HIV status.** _(time frame: weekly to week 8 then at week 24)_
- **Primary end points stratified by baseline vitamin D and L-arginine status.** _(time frame: weekly to week 8 then week 24)_
- **Primary end points stratified by ethnicity (Papuan and non-Papuan patients).** _(time frame: weekly to week 8 then week 24)_

## Locations (1)

- Timika Tuberculosis Clinic and Community Hospital, Timika, Papua Province, Indonesia

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.timika tuberculosis clinic and community hospital|timika|papua province|indonesia` — added _(2026-05-12)_

---

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