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Am J Respir Crit Care Med. 2009 May 1;179(9):843-50. doi: 10.1164/rccm.200804-567OC. Epub 2009 Jan 29.

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

Author information

1
Infectious Disease Research Unit, Aarhus University Hospital, Skejby, Brendstrupgaardsvej, 8200 Aarhus N, Denmark. wejse@dadlnet.dk

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).

PMID:
19179490
DOI:
10.1164/rccm.200804-567OC
[Indexed for MEDLINE]

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