Vitamin D as Supplementary Treatment for Tuberculosis: A Double-blind, Randomized, Placebo-controlled Trial.
Wejse, Christian 1,2; Gomes, Victor F. 1; Rabna, Paulo 1; Gustafson, Per 1,3; Aaby, Peter 1; Lisse, Ida M. 4; Andersen, Paul L. 2; Glerup, Henning 5; Sodemann, Morten 1,6
[Miscellaneous]
American Journal of Respiratory & Critical Care Medicine.
179(9):843-850, May 1, 2009.
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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, placebo-controlled 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 1 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).
(C) 2009 American Thoracic Society