Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial.

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, 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).

authors

Wejse C,Gomes VF,Rabna P,Gustafson P,Aaby P,Lisse IM,Andersen PL,Glerup H,Sodemann M

doi

10.1164/rccm.200804-567OC

subject

Has Abstract

pub_date

2009-05-01 00:00:00

pages

843-50

issue

9

eissn

1073-449X

issn

1535-4970

pii

200804-567OC

journal_volume

179

pub_type

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