Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis
Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis
Tuberculosis (TB) is the second largest infectious disease that causes death in the last 4
 centuries in all the world. Observational studies found an association between vitaminD and
 TB, suggesting a potential therapeutic role of vitaminD supplementation in patients with
 active tuberculosis. The hypothesis is that the administration of vitaminD is associated with
 changes in the levels of cytokines in patients with tuberculosis treated with first-line
 drugs. The aim of this study is to evaluate the effect of vitaminD supplementation on the
 clinical course, the time of negative smears and cultures, and the effect on the immune
 response in patients with pulmonary tuberculosis (TBP).
We are going to include of 60 patients diagnosed with confirmed TBP with and without diabetes
 mellitus, by positive smear and culture for Mycobacterium tuberculosis sensitive to
 first-line drugs (rifampicin, isoniazid, pyrazinamide and ethambutol), which will be grouped
 as follows: 1) patients who receive vitamin D (VD) (n = 30) and 2) patients who not receive
 vitamin D (NVD) (n = 30) in addition to drug treatment of tuberculosis drug frontline. Blood
 samples must be taken each month until the end of treatment.The VD group of participants will
 receive treatment with a daily dose of Vitamin D 200 International Units (IU) during the
 first two months of treatment. All Patients who participate must give their written consent.

 First, we are going to separate the peripheral blood mononuclear cells with Ficoll reagent.
 Then, for the determination of intracellular cytokines in basal conditions and after the
 antigenic stimulation with M.tuberculosis, the flow cytometric technique is going to be used
 and the results will be analyzing in a flow cytometer. We are going to infected cells with M.
 tuberculosis strain at a multiplicity of infection (MOI) of 1 and 10, in order to determinate
 phagocytosis and bactericidal activity of peripheral whole blood of patients, using Colony
 Forming Units (CFU) and staining. Extraction of RNA will be performed according to the kit
 supplier. The amplification reaction is going to perform with Applied Biosystems and Sybr
 Green Master Mix. We are going to use the unpaired Student t test, for the normal
 distribution parameters.
Inclusion Criteria:

 -  Men and women over 18 and under 65 years old, diagnosed with tuberculosis confirmed by
 positive smear and positive culture, without documented evidence of previous treatment
 for TB, with hemoglobin values greater than 10 g / dL, and written concent.

 Exclusion Criteria:

 -  Patients diagnosed with HIV, or who do not give written concent, patients with chronic
 lung disease, patients with clinical evidence of infectious or chronic inflammatory
 disease processes such as; rheumatoid arthritis, patients with chronic lung disease,
 systemic lupus erythematosus (SLE), Sjögren Sx, dermatomyositis, scleroderma,
 seronegative arthritis, gout, inflammatory bowel disease, chronic active hepatitis,
 glomerulonephritis, rheumatic fever and patients with cardiac disease, cancer, and
 patients with a history of alcohol or drug abuse.