Please select the eligibility criteria that correspond to the clinical trial below.
Title: Supplementation of Vitamin B12 in Pregnancy and Postpartum on Growth and Cognitive Functioning in Early Childhood: A Randomized, Placebo Controlled Trial
Brief Summary: Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut function may decrease absorption. Vitamin B12 is crucial for normal cell division and differentiation, and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation to pregnant women on neurodevelopment and growth of their children. We also aim to measure the impact of B12 supplementation on several other outcomes.

Study design: Individually randomized double-blind placebo controlled trial in pregnant South Asian women at risk of poor vitamin B12 status. Participants will be randomized in a 1:1 ratio.

Study participants and site: 800 pregnant women from early pregnancy. Women will be enrolled as early as possible, but no later than in week 15 of pregnancy.

Intervention: Daily administration of 50 µg of vitamin B12 from early pregnancy until 6 months after birth.

Comparator: Placebo, identical to the vitamin B12 supplements.

Outcomes: Primary: (i) neurodevelopment in children measured at 6 and 12 months of age (ii) growth in children measured by weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children at 24 months (ii) gestational age at birth, (iii) fetal and infant growth measured by weight and length at birth, after 1 month and then at 3, 6, 9, and 24 months, (iv) hemoglobin concentration in children and mothers.

Relevance for programs and public health: The results from this study can suggest new dietary guidelines for South Asian women that again can lead to improved pregnancy outcomes and neurodevelopment and cognitive functioning in South Asian children.


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

-

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.

-
C: Inclusion Criteria:

* HIV negative
* 12-26 weeks gestational age at screening visit
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: A