Tuberculosis Clinical Trial
Official title:
Impact of Vitamin D Supplementation on Host Immunity to Mycobacterium Tuberculosis and Response to Treatment: Building Translational Research Capacity in Nutrition and Infectious Diseases in the Republic of Georgia
Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially
the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such
as calcium and phosphate. There is new information that links vitamin D to the functioning
of our immune system. The purpose of the study is to find out how vitamin D affects the
immune system of patients with TB. We want to find out if correcting low vitamin D levels,
in addition to getting standard therapy for TB, will help the immune system fight off TB
infection more effectively.
The study will be done at the Georgia National Center for Tuberculosis and Lung Diseases
(NCTBLD) in Tbilisi, Republic of Georgia. 220 patients with tuberculosis and 80 family
members or household contacts of patients with tuberculosis will be participating in this
study. TB patients, already receiving standard TB therapy, will be randomly assigned to
either receive the Vitamin D pill or a placebo for a total of sixteen weeks. Neither the
subject nor the investigator will know whether the subject has received the Vitamin D or the
inactive placebo.The subject will orally consume the Vitamin D/placebo tablet 3 times a week
for the 1st 8 weeks (while in hospital) and then once every other week for the last 8 weeks(
during out-patient visits to the hospital).
The main study hypothesis is that Vitamin D supplementation helps patients with
tuberculosis, who are on standard anti TB antibiotic therapy, get better faster.
This is a double-blind, randomized, controlled clinical trial on the clinical efficacy and
antimicrobial mechanisms of oral high dose vitamin D3 therapy three times weekly given for 8
weeks followed by the same vitamin D dose given every other week for a subsequent 8 weeks
(n=129) versus placebo (n=129) in newly diagnosed Georgian patients with pulmonary TB.
The trial is also designed to obtain needed information on vitamin D status and general
nutritional status in TB patients in Georgia, explore vitamin D regulation of the endogenous
antimicrobial peptide cathelicidin/LL-37 in human tissues, and obtain hypothesis-generating
data on the potential role of cathelicidin/LL-37 as a mechanism for the anti-mycobacterial
effects of vitamin D in humans.
The potential study subjects will be identified and clinically monitored by clinical study
coordinators after diagnosis by standard methods (compatible signs and symptoms, positive
sputum AFB smear and culture, chest X-ray). Medical records of all patients with newly
diagnosed tuberculosis registered for treatment at the NCTBLD in Tbilisi will be screened
for eligibility for participation in the study. Written informed consent will be obtained
from patients who met eligibility criteria and agreed to participate in the study prior to
the subject undergoing any study-related procedure. Participation in study will involve a
total of seven study visits (one baseline and six follow up visits.
TB patients will otherwise be conventionally treated with anti-TB drug regimens using the
DOTS protocols: an initial 2 month in-hospital intensive phase with daily treatment with
oral rifampicin, isoniazid, pyrazinamide and ethambutol, followed by an outpatient
continuation phase for 4 months with rifampicin and isoniazid only, given 3 times per week.
Given data that TB disease itself is associated with vitamin D depletion we will also
recruit 80 otherwise healthy, adult family members of the pulmonary TB patients as a pilot
substudy. Family members recruited will be those accompanying the TB patient to clinic.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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