Immune Reconstitution in Tuberculosis Disease

Phase 2 Completed 390 enrolled Karolinska Institutet Addis Ababa University · collab Armauer Hansen Research Institute, Ethiopia · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2012-09
Primary completion: 2015-08
Completion: 2015-08

Publications

Bekele A, Gebreselassie N, Ashenafi S, Kassa E, Aseffa G, Amogne W, Getachew M, Aseffa A, Worku A, Raqib R, Agerberth B, Hammar U, Bergman P, Aderaye G, Andersson J, Brighenti S. Daily adjunctive therapy with vitamin D3 and phenylbutyrate supports clinical recovery from pulmonary tuberculosis: a randomized controlled trial in Ethiopia. J Intern Med. 2018 Sep;284(3):292-306. doi: 10.1111/joim.12767. Epub 2018 May 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cholecalciferol	Other / unclassified	5000 iu	Oral
Comparator	Sodium Phenylbutyrate	Small molecule	500 mg	Oral

Immune Reconstitution in Tuberculosis Disease

Summary

Timeline

Publications

Drugs

Indications