Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Suspected smear positive pulmonary tuberculosis.
* Age 18 years or older.
* Written informed consent to participate.

Exclusion Criteria:

* Known intolerance of vitamin D or first-line anti-tuberculous therapy.
* Taking antituberculous therapy for more than six days in the six months preceding enrolment.
* Taking the following medication in the month preceding enrolment: oral corticosteroid therapy, immunosuppressant therapy or cytotoxic therapy.
* Taking the following medication at enrolment: benzothiadiazine derivatives, cardiac glycosides or antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol.
* Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, HIV infection, liver failure, renal failure or malignancy
* Infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing)
* Biochemical disturbance at enrolment: serum corrected calcium \>2.66 mmol/l, serum AST \>120 IU/l, total serum bilirubin \> 40 micromol/l or serum creatinine \> 250 micromol/l
* Breastfeeding or pregnancy
B: Inclusion Criteria:

1. Adults 18 years of age or older;
2. Have sputum smear positive or sputum smear negative pulmonary or extrapulmonary TB, using the standard NTP definitions for these diagnoses;
3. Have never received more that one month of anti-tuberculosis treatment in the past (that is, only new cases of TB will be included).
4. Agree to continue treatment at the clinic of diagnosis for the full eight month course of treatment.
5. Not pregnant.
6. Agree to enrol in the study.

Exclusion Criteria:

1. Children less than 18 years of age,
2. TB patients who have previously received treatment for TB for more than one month,
3. Not willing to continue treatment at the clinic for the full course.
4. TB Patient who are currently pregnant,
5. TB patients who are not willing to enrol in the study.
C: Inclusion Criteria:

1. Patient is age \> 18 years;
2. Patient has documented new case of smear-positive pulmonary TB;
3. Patient has received ≤ 1 week of anti-TB therapy;
4. The patient will receive anti-TB therapy in Tbilisi;
5. Patient has provided informed consent.

Exclusion Criteria:

1. Patient has had \> 30 days of lifetime TB therapy;
2. Patient is currently pregnant or lactating;
3. Patient has a history of organ transplant;
4. Patient has a history of cancer in past 5 years (ineligibility criteria does not include non-melanoma skin cancer);
5. Patient has a history of seizures;
6. Patient has a history of hypercalcemia;
7. Patient has a history of hyperparathyroidism;
8. Patient has a history of sarcoidosis;
9. Patient has a history of nephrolithiasis (renal stones);
10. Patient has taken oral corticosteroids in the past 30 days;
11. Patient is currently using cytotoxic or immunosuppressive drugs;
12. Patient currently has significant renal dysfunction (defined as a serum creatinine of \>250mmol/L);
13. Patient requires dialysis therapy;
14. Patient has a history of cirrhosis;
15. Patient is currently incarcerated;
16. Patient is not able to complete all study visits in at the NCTBLD in Tbilisi.
D: Inclusion Criteria:

* Adults \>15 years with sputum smear positive pulmonary TB
* New cases only
* Agree to continue treatment in Timika for the full six month course of treatment -Not pregnant
* Consent to enroll in the study.

Exclusion Criteria:

* hypercalcaemia (ionized calcium \>1.32 mmol/L) identified at baseline
* taking arginine or vitamin D

Answer: C