Please select the eligibility criteria that correspond to the clinical trial below.
Title: Micronutrient Supplementation in Conjunction With Standard Anti-Tuberculosis Therapy in Paediatric (6 Months-15 Years) New Pulmonary Tuberculosis Patients
Brief Summary: A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN) combined, but neither of them alone, significantly increased weight gain during Tuberculosis (TB) treatment. There was a substantially larger beneficial effect on survival amongst those who received the combination of Zn and MN compared with those who received either Zn alone or MN alone. These exciting preliminary findings require further confirmation, as the data on mortality reduction was based on a post-hoc subgroup-analysis. Effects of MN and Zn supplementation has not been assessed in children with TB. Studies are urgently needed to evaluate the therapeutic potential of nutritional interventions on treatment outcome in children with TB. Simple and inexpensive nutritional interventions may substantially impact TB-related child morbidity and mortality in high-burden settings. The investigators thus, propose a randomized, double blind, controlled trial that will measure the effect of multi-vitamin/mineral supplementation on the efficacy of anti-TB treatment in newly diagnosed childhood pulmonary TB patients in Delhi.


Options:
A: Inclusion Criteria:

* Informed and written consent to take part in the study
* Previously untreated and newly diagnosed smear positive Tb patients according to the WHO definitions

Exclusion Criteria:

* Hospitalization
* Pregnancy
* Known allergy against peanuts
* Chronic or acute disease other than tuberculosis/HIV
B: 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
C: 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
D: 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.

Answer: B