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:

* Born at term, as determined from last menstrual period
* Weighing \< 2.5 kg
* Resident within 12 km of the hospital and expected to continue living in the area for the following 6 months
* With no severe congenital abnormalities
* No morbidity severe enough to be expected to result in death before 7 days due to severe respiratory distress, shock, pulmonary sepsis, etc.
* Parental informed consent
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:

* HIV-infected children as defined by ≥ 2 positive HIV DNA PCRs and/or HIV cultures of blood for children less than 18 months of age, or by positive screening and confirmatory serologic testing in those older than 18 months of age
* Stable HIV disease, defined by the absence of change in HIV clinical or immunologic category during the preceding 6 month period, prior to commencing the study
* Age 3 years through 18 years
* Voluntary informed consent

Exclusion Criteria:

* Any antiretroviral medication change in the 6 months prior to the study, or any anticipated antiretroviral medication change during the duration of the study
* Active participation in another treatment trial
* Serum calcium \< 2mmol/L at baseline
D: Inclusion Criteria:

* Eligible subjects will be children age 12 to 15 years inclusive in public school, located in Songino-Khairhan district, who are residents of Ulaanbaatar, and whose parents have given informed consent and who accent to participate in the study.

Exclusion Criteria:

* Individuals with pre-existing calcium, parathyroid conditions, or type I diabetes, sarcoidosis, or who require chronic diuretic therapy including calcium channel blockers, or who are cognitively impaired.

Answer: B