Vitamin D as Supplementary Treatment for Tuberculosis A Double-blind, Randomized, Placebo-controlled Trial
(2009) In American Journal of Respiratory and Critical Care Medicine 179(9). p.843-850- Abstract
- Rationale Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. Objectives: To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. Methods: We conducted a randomized, double-blind, place-bocontrolled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment. Measurements and Main Results: The primary outcome was reduction in a clinical severity score (TBscore) for all... (More)
- Rationale Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. Objectives: To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. Methods: We conducted a randomized, double-blind, place-bocontrolled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment. Measurements and Main Results: The primary outcome was reduction in a clinical severity score (TBscore) for all patients with pulmonary TB. The secondary outcome was 12-month mortality. No serious adverse effects were reported; mild hypercalcemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo. Overall mortality was 15% (54 of 365) at I year of follow-up and similar in both arms (30 of 187 for vitamin D treated and 24 of 178 for placebo; relative risk, 1.19 [0.58-1.95]). HIV infection was seen in 36% (131 of 359): 21% (76 of 359) HIV-1, 10% (36 of 359) HIV-2, and 5% (19 of 357) HIV-1+2. Conclusions: Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB; it is possible that the dose used was insufficient. Clinical trial registered with www.controlled-trials.com/isrctn (ISRCTN35212132). (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/1428170
- author
- Wejse, Christian ; Gomes, Victor F. ; Rabna, Paulo ; Gustafson, Per LU ; Aaby, Peter ; Lisse, Ida M. ; Andersen, Paul L. ; Glerup, Henning and Sodemann, Morten
- organization
- publishing date
- 2009
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- randomized clinical trial, vitamin D, tuberculosis, clinical score, HIV
- in
- American Journal of Respiratory and Critical Care Medicine
- volume
- 179
- issue
- 9
- pages
- 843 - 850
- publisher
- American Thoracic Society
- external identifiers
-
- wos:000265665000014
- scopus:65549143064
- ISSN
- 1535-4970
- DOI
- 10.1164/rccm.200804-567OC
- language
- English
- LU publication?
- yes
- id
- 4c5ecb6e-8c7d-4733-9d45-064ee62b7e7e (old id 1428170)
- date added to LUP
- 2016-04-01 12:22:29
- date last changed
- 2022-04-21 06:32:28
@article{4c5ecb6e-8c7d-4733-9d45-064ee62b7e7e, abstract = {{Rationale Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. Objectives: To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. Methods: We conducted a randomized, double-blind, place-bocontrolled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment. Measurements and Main Results: The primary outcome was reduction in a clinical severity score (TBscore) for all patients with pulmonary TB. The secondary outcome was 12-month mortality. No serious adverse effects were reported; mild hypercalcemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo. Overall mortality was 15% (54 of 365) at I year of follow-up and similar in both arms (30 of 187 for vitamin D treated and 24 of 178 for placebo; relative risk, 1.19 [0.58-1.95]). HIV infection was seen in 36% (131 of 359): 21% (76 of 359) HIV-1, 10% (36 of 359) HIV-2, and 5% (19 of 357) HIV-1+2. Conclusions: Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB; it is possible that the dose used was insufficient. Clinical trial registered with www.controlled-trials.com/isrctn (ISRCTN35212132).}}, author = {{Wejse, Christian and Gomes, Victor F. and Rabna, Paulo and Gustafson, Per and Aaby, Peter and Lisse, Ida M. and Andersen, Paul L. and Glerup, Henning and Sodemann, Morten}}, issn = {{1535-4970}}, keywords = {{randomized clinical trial; vitamin D; tuberculosis; clinical score; HIV}}, language = {{eng}}, number = {{9}}, pages = {{843--850}}, publisher = {{American Thoracic Society}}, series = {{American Journal of Respiratory and Critical Care Medicine}}, title = {{Vitamin D as Supplementary Treatment for Tuberculosis A Double-blind, Randomized, Placebo-controlled Trial}}, url = {{http://dx.doi.org/10.1164/rccm.200804-567OC}}, doi = {{10.1164/rccm.200804-567OC}}, volume = {{179}}, year = {{2009}}, }