Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis

NCT02464683 | Unknown Phase 4 DMC

• 1 other identifier: INERC50-13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Determination of cytokines

  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.

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

VitaminD

EXPERIMENTAL

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

Interventions

VitaminD DIETARY_SUPPLEMENT

200 International Units (oral dose) daily of 60 days

VitaminD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias: lead

Study Sites (1)

Martha Torres Rojas

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (3)

• Gibney KB, MacGregor L, Leder K, Torresi J, Marshall C, Ebeling PR, Biggs BA. Vitamin D deficiency is associated with tuberculosis and latent tuberculosis infection in immigrants from sub-Saharan Africa. Clin Infect Dis. 2008 Feb 1;46(3):443-6. doi: 10.1086/525268.

  PMID: 18173355 RESULT

• Nnoaham KE, Clarke A. Low serum vitamin D levels and tuberculosis: a systematic review and meta-analysis. Int J Epidemiol. 2008 Feb;37(1):113-9. doi: 10.1093/ije/dym247.

  PMID: 18245055 RESULT

• Martineau AR, Timms PM, Bothamley GH, Hanifa Y, Islam K, Claxton AP, Packe GE, Moore-Gillon JC, Darmalingam M, Davidson RN, Milburn HJ, Baker LV, Barker RD, Woodward NJ, Venton TR, Barnes KE, Mullett CJ, Coussens AK, Rutterford CM, Mein CA, Davies GR, Wilkinson RJ, Nikolayevskyy V, Drobniewski FA, Eldridge SM, Griffiths CJ. High-dose vitamin D(3) during intensive-phase antimicrobial treatment of pulmonary tuberculosis: a double-blind randomised controlled trial. Lancet. 2011 Jan 15;377(9761):242-50. doi: 10.1016/S0140-6736(10)61889-2. Epub 2011 Jan 5.

  PMID: 21215445 RESULT

Related Links

• World Health Organization webpage.

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Edith Escudero, Degree

  Instituto Nacional de Enfermedades Respiratorias

  STUDY DIRECTOR

Central Study Contacts

MARTHA TORRES ROJAS, PhD

CONTACT

54871700; marthatorres98@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairwoman of Microbiology Research Department

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: June 8, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: June 8, 2015

Record last verified: 2015-03

Locations

ME (1)