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

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


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 (ISRCTN35212132).

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antitubercular Agents / therapeutic use
  • CD4 Lymphocyte Count
  • Cholecalciferol / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Guinea-Bissau / epidemiology
  • HIV Infections / epidemiology
  • Humans
  • Male
  • Tuberculosis, Pulmonary / drug therapy*
  • Tuberculosis, Pulmonary / mortality
  • Vitamin D / blood
  • Vitamin D Deficiency / drug therapy
  • Vitamin D Deficiency / epidemiology
  • Vitamins / therapeutic use*
  • Weight Gain


  • Antitubercular Agents
  • Vitamins
  • Vitamin D
  • Cholecalciferol

Associated data

  • ISRCTN/ISRCTN35212132