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Immune Reconstitution in Tuberculosis Disease

NCT01698476 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2016-02-05

No results posted yet for this study

Summary

The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary tuberculosis.

Conditions

  • Pulmonary Tuberculosis (TB)

Interventions

DRUG

vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.

DRUG

Placebo tablets

Sponsors & Collaborators

  • Addis Ababa University

    collaborator OTHER

  • Armauer Hansen Research Institute, Ethiopia

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Susanna Brighenti, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Ethiopia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01698476 on ClinicalTrials.gov