Article

Vitamin D as Supplementary Treatment for Tuberculosis, a Double-blind, Randomized, Placebo-controlled Trial

Infectious Disease Research Unit, Aarhus University Hospital, Skejby, Brendstrupgaardsvej, 8200 Aarhus N, Denmark.
American Journal of Respiratory and Critical Care Medicine (Impact Factor: 11.99). 02/2009; 179(9):843-50. DOI: 10.1164/rccm.200804-567OC
Source: PubMed

ABSTRACT Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis.
To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality.
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.
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.
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).

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Available from: Christian Wejse, Mar 06, 2014
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    • "It was therefore tempting to test whether vitamin D could be used as a dietary supplement in TB treatment, since historically vitamin D sources like sunbathing and cod liver oil were used to treat TB. Many clinical trials have been performed to test this hypothesis; the results have however been inconclusive, with several studies showing positive results, especially in patients with vitamin D deficiency (Salahuddin et al. 2013; Kearns et al. 2014), but many other major clinical trials showing no benefits overall (Wejse et al. 2009; Martineau et al. 2011; Ralph et al. 2013; Kearns et al. 2014). It is still uncertain whether vitamin D will have any use in TB therapy, with some researchers advocating that better knowledge is needed about vitamin D concentrations for optimal immune response in order to perform adequate clinical trials (Ralph et al. 2013). "
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