Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial.
BACKGROUND
Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis.


OBJECTIVE
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.


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).
Wejse
Christian
C
Infectious Disease Research Unit, Aarhus University Hospital, Skejby, Brendstrupgaardsvej, 8200 Aarhus N, Denmark. wejse@dadlnet.dk
Gomes
Victor F
VF
Rabna
Paulo
P
Gustafson
Per
P
Aaby
Peter
P
Lisse
Ida M
IM
Andersen
Paul L
PL
Glerup
Henning
H
Sodemann
Morten
M
D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D002762:Cholecalciferol / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006169:Guinea-Bissau / Q000453:epidemiology; D015658:HIV Infections / Q000453:epidemiology; D006801:Humans; D008297:Male; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy* / Q000401:mortality; D014807:Vitamin D / Q000097:blood; D014808:Vitamin D Deficiency / Q000188:drug therapy / Q000453:epidemiology; D014815:Vitamins / Q000627:therapeutic use*; D015430:Weight Gain
D000995:Antitubercular Agents; D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol