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

NCT00677339 | Completed Phase 3 DMC

• 1 other identifier: AVDAPT 1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Smear Positive Pulmonary Tuberculosis

Keywords

Tuberculosis; Adjunctive therapy; L-arginine; Nitric oxide; Vitamin D

Outcome Measures

Primary Outcomes (2)

• Proportion of pulmonary TB patients who are culture negative at 1 month

  1 month

• Difference in improvement in composite clinical endpoint comprising weight, cough clearance and FEV1 at 2 months.

  2 months

Secondary Outcomes (17)

• Change in plasma L-arginine concentration

  week 0, 2, 4, 8, 24

• Change in plasma 25(OH)D3 concentration

  week 0, 2, 4, 8, 24

• Death, clinical failure and default independently, and 'death or clinical failure or default'.

  week 24

• Hypercalcaemia

  week 0, 2, 4, 8, 24

• Gastrointestinal side effects

  weekly to week 8 then at week 24

Study Arms (4)

1

ACTIVE COMPARATOR

Active L-arginine plus active vitamin D

Drug: L-arginine; Drug: Vitamin D

2

ACTIVE COMPARATOR

Placebo L-arginine plus active Vitamin D

Drug: Vitamin D; Drug: Placebo L-arginine

3

ACTIVE COMPARATOR

Active L-arginine plus placebo vitamin D

Drug: L-arginine; Drug: Placebo Vitamin D

4

PLACEBO COMPARATOR

placebo L-arginine plus placebo vitamin D

Drug: Placebo L-arginine; Drug: Placebo Vitamin D

Interventions

L-arginine DRUG

L-arginine 6g orally daily

Also known as: Argimax

1; 3

Vitamin D DRUG

Cholecalciferol 50000 IU once monthly orally

Also known as: Calciferol Strong

1; 2

Placebo L-arginine DRUG

placebo L-arginine once daily

2; 4

Placebo Vitamin D DRUG

placebo vitamin D orally once monthly

3; 4

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• hypercalcaemia (ionized calcium \>1.32 mmol/L) identified at baseline
• taking arginine or vitamin D

Sponsors & Collaborators

• Menzies School of Health Research: lead
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: collaborator
• Australian National University: collaborator

Study Sites (1)

Timika Tuberculosis Clinic and Community Hospital

Timika, Papua Province, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 23967066 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Arginine; Vitamin D

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nicholas M Anstey, MBBS

  Menzies School of Helath Research

  STUDY DIRECTOR

• Anna P Ralph, MBBS

  Australian National University, Canberra, Australia

  PRINCIPAL INVESTIGATOR

• Franciscus Thio, MPPM

  District Ministry of Health, Timika

  PRINCIPAL INVESTIGATOR

• Peter Morris, MBBS

  Menzies School of Health Research, Northern Territory, Australia

  PRINCIPAL INVESTIGATOR

• Enny Kenangalem, MD

  Papuan Community Health and Development Foundation

  PRINCIPAL INVESTIGATOR

• Jeanne R Poespoprodjo, MD

  Mimika District Health Authority

  PRINCIPAL INVESTIGATOR

• Richard N Price, MD

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

• Tonia Woodberry, PhD

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

• Paul M Kelly, MBBS

  Australian Capital Territory Department of Health

  PRINCIPAL INVESTIGATOR

• Emiliana Tjitra, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Sandjaja Sandjaja, PhD

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

  PRINCIPAL INVESTIGATOR

• Dina B Lolong, MD

  National Institute of Health Research and Development

  PRINCIPAL INVESTIGATOR

• Mark Chatfield, PhD

  National Health and Medical Research Council (Australia) Clinical Trials Centre

  PRINCIPAL INVESTIGATOR

• Ivan Bastian, MBBS

  Institute of Medical and Veterinary Pathology, South Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Global and Tropical Health

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 14, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

ID (1)