Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Vitamin B12 Fortified Milk Supplementation During Pregnancy and 6 Month Postpartum to Improve B12 Status and Child Development
Brief Summary: Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth defects and common complications (e.g. intrauterine growth restriction, neural tube defects), and possibly immune function impairment. The newborns and infants of B12-deficient mothers have low B12 stores at birth, further exacerbated by a very low concentration of B12 in breast milk that may hinder their growth and development. In regions such as Bangladesh, many women of reproductive age have inadequate B12 status, probably due to low intake of animal source food. Vitamin B12 intake and status in pregnancy and lactation is potentially insufficient to prevent impaired child development and immune function related to inadequate B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1) biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive immunity in infants; (3) neurological and cognitive function in infants.


Options:
A: Inclusion Criteria:

* Pregnant mother in early pregnancy and not later than 15 weeks of pregnancy.
* Current resident and plan to reside in Bhaktapur district for at least the next 2 years.
* Age of mother between 18 and 40 years.
* Consent to participate in the study.

Exclusion Criteria:

* Taking or plan to take dietary or multivitamin supplements containing vitamin B12.
* Known case of chronic disease like asthma, tuberculosis, diabetes, hypertension, hypo or hyperthyroidism or others
* Known case of current high risk pregnancy
* Severe anemia (hemoglobin concentration \<7 g/dL).
* Where the study doctor finds it necessary to treat the woman with vitamin B12 or vitamin B12 containing supplements
B: Inclusion Criteria:

1. 18 - 35 y old 2. 11-14 wk pregnant (based on last menstrual period) 3. Willing to stay in Dhaka during pregnancy and remain in the area for the 12 mo following recruitment 4. Willing to be admitted in the clinic for delivery 5. Intends to exclusively or predominantly breastfeed infant until 6 mo of age

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Exclusion Criteria:

1. Women with severe anemia; Hb concentration \<70 g/L 2. History or presence of systemic disease such as Diabetes mellitus, Hypertension 3. History of previous complicated pregnancies, pre-term delivery, or abortion 4. Current use of supplements containing vitamin B12 5. Children with acute illness or features suggestive of any chronic disease such as tuberculosis, any congenital anomalies such as cleft lip or palate.

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C: Inclusion Criteria:

* Age: 6 to 30 months
* Either sex
* Likely to reside in area for next 6 months

Exclusion Criteria:

* Severe systemic illness requiring hospitalization
* Severe malnutrition, i.e. weight for height \< -3 z of the WHO standard for this age group. For ethical reasons these children require micronutrient supplementation and adequate medical care.
* Non consent
* Consuming vitamin supplements that include folic acid and vitamin B12.
* Severe anemia (Hb \< 7 g/dL).
D: Inclusion Criteria:

* Pregnant women at or before 14 weeks gestational age.

Exclusion Criteria:

* Women who anticipate moving outside of the study area before study completion
* Those with twin or multiple pregnancies
* Those who test positive for hepatitis B (HepBSAg), HIV or Syphilis (VDRL)
* Those taking vitamin supplements in addition to folate and iron
* Those with a serious pre-existing medical condition, defined as conditions that require chronic or daily medical therapy such as connective tissue diseases, hypertension not related to pregnancy, inflammatory bowel disease, active tuberculosis, symptomatic heart disease, and insulin dependent diabetes.

Answer: B