Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial
Brief Summary: There are currently no interventions available to substantially reduce the incidence of low birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation and possibly improved energy intakes.

The current view of the medical and public health community in India is that the immediate focus should be on promoting survival and development of low birth weight infants who have nearly a 6 to 7 fold higher mortality during infancy than those with normal birth weight.

Low serum zinc is associated with increased incidence of diarrhea and pneumonia. There is sufficient evidence in under-threes that during acute illness, zinc supplementation (1-2 recommended dietary allowance \[RDA\]) reduces incidence of all episodes of diarrhea, severe diarrhea and pneumonia. A number of initial published trials also show significant effect of zinc treatment on pneumonia. With the large and consistent effects of zinc supplementation on the incidence and severity of infections, an effect on child mortality is likely.

Available literature suggests the distinct possibility of reduced neonatal and infant mortality in LBWs receiving 1 RDA of zinc daily. A pilot study in India showed a 54% reduction in mortality in LBW infants. These findings were based on a very small sample and therefore considered insufficient to change policy.

A positive impact in the proposed study will provide an important tool for reduction of infant mortality which is currently stagnant and government acceptance for such a program is likely to be very high. We, the researchers at the Society for Applied Studies, believe this study has the potential for decreasing infant mortality from its current level.


Options:
A: Inclusion Criteria:

* Infants aged 14 to 28 days born after 37 weeks of gestation and weighing less than or equal to 2.5 kg at birth (\<10th percentile of the National Center for Health Statistics \[NCHS\] median birth weight)
* Either sex
* Resides within 7 km of the hospital

Exclusion Criteria:

* Likely to leave the area of residence within 6 months of enrollment
* Congenital malformations, congenital heart disease, metabolic disorders, renal diseases, etc.
* Non consent for participation
* Illness requiring hospitalization
* Twins
* Preterm
B: Inclusion Criteria:

* Singleton, live born infants born to HIV- negative women
* Mothers will need to have registered for pre-natal care before 34 weeks gestation
* intend to stay in Dar es Salaam for until delivery and 18 months thereafter.

Exclusion Criteria:

* infants born with multiple congenital abnormalities
C: Inclusion Criteria:

* All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal.

Exclusion Criteria:

* Parent refusal
D: Inclusion Criteria:

4-6 months of age (stratified by HIV status) Infant able to take oral preparations Consent of parent/guardian HIV status obtained from mother and child

Exclusion Criteria:

Documented micronutrient supplementation other than vitamin A in the preceding month Less than 60% of mean weight for age by NCHS guidelines (micronutrient intervention obligatory according to WHO guidelines for management of severely malnourished children) Persistent diarrhea (\>=7 days) at the time of study enrollment Exclusive breastfeeding Infants in whom a second confirmatory HIV test cannot be obtained (when required) Co-enrollment of the infant in other clinical intervention trials e.g. antibiotic or vaccine trials

Answer: A