Please select the eligibility criteria that correspond to the clinical trial below.
Title: Vitamin B12 Supplementation in Addition to Folic Acid and Iron Improves Hematological and Biochemical Markers in Pregnancy: a Randomized Controlled Trial
Brief Summary: Pregnancy is associated with increased requirements for iron and increased blood volume of up to 40%. Because expansion in plasma volume is higher than the increase in the mass of red blood cells, there is a fall in hemoglobin concentration, which leads to physiological anemia, characterized with lower hemoglobin (Hb), hematocrit and red blood cells, but without changes in mean corpuscular volume (MCV). Anemia in pregnancy is defined with Hb values under 110 g/L in the first trimester and under 105 g/L in the second and third trimester.

Iron deficiency is thought to be the most common nutrient deficiency among pregnant women. Consequences of anemia include delayed fetal growth, premature delivery, intrauterine fetal death, postpartum depression and delayed psychomotor development of a child. It is known that in women that are not anemic daily iron supplementation of 27 mg/day is sufficient, which can be obtained from adequate nutrition or body supplies. Iron supplementation is pregnancy has been recommended by the WHO (World Health Organisation) since 1959, and this recommendation was confirmed by numerous professional associations. However, in women with anemia, or women subjected to particular dietary regimens with diminished quantity of iron, including vegetarian or vegan diet, required supplementation dosage is higher, and estimated in the literature to be 120 mg/day.

The aim of this study was to analyze whether adding vitamin B12 (5 µg /100 days), along with folic acid and iron as supplement in pregnant women who are not anemic and who need only iron supplementation, will result in improvements of hematological and biochemical markers.


Options:
A: Inclusion Criteria:

* healthy women from 8th week of pregnancy

Exclusion Criteria:

* existence of hypertension
* existence of diabetes
* existence of genetic abnormalities
* smoking
* previous miscarriage
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:

1. Availability of informed verbal consent
2. Plan to reside in the defined study area for the next 12 months
3. Mothers intend to breastfeed their children for at least 8 months, and exclusively for 4 months

Exclusion Criteria:

1. Severe systemic illness requiring hospitalization
2. Growth retardation
3. Severe congenital malformations
4. Plasma cobalamin concentration \<148 pmol/L (These children will be treated for vitamin B12 deficiency and not included in the RCT, but will be included in the cohort design)
D: 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

Answer: A