Immune Reconstitution in Tuberculosis Disease (IRETB)

Karolinska Institute

Status and phase: Completed; Phase 2

Conditions: Pulmonary Tuberculosis (TB)

Treatments: Drug: Placebo tablets; Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Study type: Interventional

Funder types: Other

Identifiers

NCT01698476

IRETB-2012

Details and patient eligibility

About

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.

Enrollment: 390 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

HIV negative patients, adult patients >18 years who has not started anti-TB therapy.

Newly diagnosed pulmonary TB confirmed by microscopy or culture but also sputum-negative clinical TB cases (defined according to the WHO 2006 criteria for sputum smear-negative TB ie. clinical symptoms of TB, chest X-ray findings and response to standard treatment).

Exclusion criteria

Patients who have already started treatment with anti-TB drugs for more that 5 days.

HIV-positive patients.

History of anti-TB treatment in the past 2 years.

Local extra-pulmonary TB in the absence of lung manifestations.

Hypercalcaemia (serum calcium > 3 mmol/L) identified at baseline.

Pregnant and breast feeding women.

Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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390 participants in 2 patient groups, including a placebo group

vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Active Comparator group

Description:

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.

Treatment:

Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Placebo tablets

Placebo Comparator group

Description:

Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.

Treatment:

Drug: Placebo tablets