Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Trial of Oral Phenylbutyrate and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis in Bangladesh: a Pilot Study
Brief Summary: Vitamin D exerts its effects via the Vitamin D Receptor (VDR) present in activated macrophages and induces expression and release of the cathelicidin, LL-37, a human antimicrobial peptide involved in killing of MTB. We aimed to investigate whether treatment of newly diagnosed pulmonary TB patients for 2 months with adjunctive PBA and vitamin D (Cholecalciferol) in combination with standard DOTS therapy (i) can improve response to standard short course TB therapy towards a rapid recovery; (ii) can induce expression of LL-37 in macrophages; (iii) can enhance killing capacity of macrophages isolated from TB patients infected in vitro with MTB; and (iv) does not evoke any adverse effects.


Options:
A: Inclusion Criteria:

* Men and women, age 18 to 60 years inclusive
* At least two positive sputum smears for tuberculosis
* Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
* Subjects who grant informed consent to participation

Exclusion Criteria:

* Karnofsky score \< 40%
* Hemoglobin \< 8.5 g/dl
* Having had treatment for TB exceeding 4 weeks in the last 5 years
* Pregnant women
B: Inclusion Criteria:

* Adults, 18-60 years with sputum smear positive pulmonary TB
* New cases only
* Gender, both
* Consent to enroll in the study

Exclusion Criteria:

* Hypercalcaemia (serum calcium \> 2.6 mmol/L) identified at baseline
* Taking vitamin D
* Pregnant and lactating
* Any known liver or kidney function abnormality, malignancy
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:

* New pulmonary (including pleural) tuberculosis with/without an extrapulmonary lesion in children age 6 months to 15 years

Exclusion Criteria:

* Weight for height \< 70 % of NCHS median (reason: zinc as per guidelines is given as standard point of care to all severely malnourished children)
* Bilateral pedal oedema
* Known HIV + ve
* Place of residence outside Delhi (including physicians discretion)
* History of previous ATT treatment or INH prophylaxis for more than 48 hours prior to enrollment
* Signs of upper airway obstruction, or an arterial oxygen saturation less than 92% in room air
* Signs of renal, hepatic, or cvs disease
* Unable to attend follow up session for reading of Mantoux tests
* Documented intake of zinc continuously for \> 2 weeks in the preceding 4 weeks at enrollment
* CNS, osteo-articular, pericardial, renal TB
* History of contact with a documented case of drug resistant TB

Answer: B