Trials / Completed
CompletedNCT01698476
Immune Reconstitution in Tuberculosis Disease
Immune Reconstitution in Tuberculosis Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 390 (actual)
- Sponsor
- Karolinska Institutet · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2012-10-03
- Last updated
- 2016-02-05
Locations
1 site across 1 country: Ethiopia
Source: ClinicalTrials.gov record NCT01698476. Inclusion in this directory is not an endorsement.