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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
Sponsor:
Information provided by (Responsible Party):
Martha Torres Rojas, Instituto Nacional de Enfermedades Respiratorias

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pulmonary Tuberculosis Dietary Supplement: VitaminD Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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.
Experimental: VitaminD
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: MARTHA TORRES ROJAS, PhD 54871700 ext 5117 marthatorres98@yahoo.com

Locations
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Mexico
Martha Torres Rojas Recruiting
Mexico city, DF, Mexico, 14080
Contact: Marcela Muñoz, MD    54871700 ext 5166    dra_munoz@hotmail.com   
Contact: Jose A. Martinez, MD    54871700 ext 5258    jarturoinfectologia@iner.gob.mx   
Sponsors and Collaborators
Instituto Nacional de Enfermedades Respiratorias
Investigators
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Study Director: Edith Escudero, Degree Instituto Nacional de Enfermedades Respiratorias
Additional Information:
Publications of Results:
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Responsible Party: Martha Torres Rojas, Chairwoman of Microbiology Research Department, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier: NCT02464683    
Other Study ID Numbers: INERC50-13
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents