Completed
PHASE2
INTERVENTIONAL
NCT01698476
Immune Reconstitution in Tuberculosis Disease
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
Type:
DRUG
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.
Name:
Placebo tablets
Type:
DRUG
Description:
Primary Outcomes
Measure:
Composite clinical TB score
TimeFrame:
0 (baseline) compared to 8 weeks.
Description:
A previously described composite clinical TB score will be used to monitor the efficacy of vitamin D and phenylbutyrate treatment among TB patients on standard chemotherapy. The numerical TB score will include self-reported clinical symptoms (cough, night sweats and chest pain) as well as different parameters determined upon clinical examination anemia, haemoptysis, dyspnoea, tachycardia, positive finding at lung auscultation, fever, low body mass index (BMI) and low mid upper arm circumference (MUAC). The TB score will be determined at the time of diagnosis (time point 0) and at 4, 8, 16 and 24 weeks after initiation of antimicrobial treatment with vitamin D and phenylbutyrate. The primary endpoint will be assessed at time point 8 weeks compared to baseline (time point 0).
Trial Information
NCT ID
NCT01698476
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Karolinska Institutet
Last Updated
December 15, 2025