Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda: a Randomised Double Blind Placebo-Controlled Trial
Brief Summary: Micronutrient deficiencies are common in HIV infected children and are aggravated by poor nutrition, especially in poor resource countries such as Uganda. It appears that micronutrient deficiencies contribute to immune dysfunction, increased morbidity and HIV disease progression. Hitherto, there has been no randomised controlled trial to assess the effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected children in Africa. Therefore, the investigators shall carry out a randomised controlled trial to determine the effect of multiple micronutrient supplementation on morbidity, weight gain and mortality among HIV infected children aged 1 to 5 years in Uganda.

Hypothesis: Daily administration of twice the recommended dietary allowance (2RDA) of multiple micronutrients to HIV infected children aged one to five years, for 6 months, will reduce all cause mortality from 24% to 14.4% in one year and result in a weight gain difference of 150 grams.


Options:
A: Inclusion Criteria:

* Healthy singleton term born infants of appropriate size for gestational age (AGA) according to the Centers for Disease Control growth charts based on weight at birth between the 5th and 95th percentiles for sex; and born to healthy breastfeeding women. This allows us to assess growth and bone mineral accretion without bias of intrauterine growth restriction.

Exclusion Criteria:

* Infants of mothers with history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes due to malabsorption of vitamin D (celiac disease, Crohn's etc.); and multiple births.
* Should any exclusion criteria be identified after recruitment, the infant will be excluded from the main analyzes, but followed in a separate arm as intent-to-treat.
B: Inclusion Criteria:

* Aged 1 to 5 years
* HIV infection (previously confirmed by 2 ELISAs for children \> 18 months; DNA PCR for those \< 18 months)
* Informed consent from the parent/caretaker
* Ability to return for follow-up (lives within a radius of 15 km from hospital and unlikely to change residence during the course of the study)

Exclusion Criteria:

* Children already enrolled in other studies
* Children with severe abnormalities which are likely to impair oral intake (for example, severe cerebral palsy)
* Severely ill children requiring urgent admission and resuscitation
C: 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
D: 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

Answer: B