Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis (VitaminD)
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|ClinicalTrials.gov Identifier: NCT02464683|
Recruitment Status : Unknown
Verified March 2015 by Martha Torres Rojas, Instituto Nacional de Enfermedades Respiratorias.
Recruitment status was: Recruiting
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Tuberculosis||Dietary Supplement: VitaminD||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis in the National Institute of Respiratory Diseases|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
Placebo Comparator: Placebo
The patient will take a single tablet of placebo daily for 60 days. Each patient will go to the hospital in order to take the blood sample.
The patient will take a single tablet of Vitamin D (200 International Units) daily for 60 days. Each patient will go to the hospital in order to take the blood sample.
Dietary Supplement: VitaminD
200 International Units (oral dose) daily of 60 days
- Determination of cytokines [ Time Frame: 6 months ]First, we are going to separate the peripheral blood mononuclear cells with Ficoll reagent. Cells were adjusted and placed in 1 mL tubes, with an antibody will be incubated for 15 min. at room temperature. Anti-antibody corresponding isotypes are going to incubate for 20 min at room temperature. The cells are going to be fixed with 1% paraformaldehyde before acquiring and analyzing in the flow cytometer. The concentration of Interleucin 17 (IL-17), Interferon-g and Tumor Necrosis Factor-a in culture supernatants of infected cells in vitro with M.tuberculosis are going to be measure. We are going to determinate them by ELISA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464683
|Contact: MARTHA TORRES ROJAS, PhD||54871700 ext email@example.com|
|Study Director:||Edith Escudero, Degree||Instituto Nacional de Enfermedades Respiratorias|