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

NCT02464683 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-06-08

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

VitaminD

200 International Units (oral dose) daily of 60 days

Sponsors & Collaborators

  • Instituto Nacional de Enfermedades Respiratorias

    lead OTHER_GOV

Principal Investigators

  • Edith Escudero, Degree · Instituto Nacional de Enfermedades Respiratorias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464683 on ClinicalTrials.gov