Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT03783104
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to give full consent (record if verbal consent is being used)
* First presentation of the mother to the antenatal clinic \<12 weeks of gestation (mothers presenting later not included as the investigators may miss a proportion of the brain growth period)
* Vegetarian mothers (higher risk of deficiency; defined as self-reported dietary pattern that includes vegans and/or people who do eat egg and/or people who do consume milk and/or meat/fish \< once a month)
* Mother is expecting singleton birth
* Living within an a-priori defined geographical area (to enhance efficiency of follow-up): Delhi - National Capital Region; Nepal - 10km radius of Paropakar Maternity \& Women's Hospital, Kathmandu valley including the three districts of Kathmandu, Bhaktapur and Lalitpur.
* Is familiar with English, Hindi, or Nepalese
Exclusion Criteria:
* Younger mothers (\<18 years; higher risk of neonatal morbidity)
* Maternal Age\>35 years ( higher risk of neonatal morbidity)
* Mothers already on medicinal B12 supplementation including as B-complex or multivitamins (confounder)
* Women with multiple gestation, those diagnosed with chronic medical conditions (diabetes mellitus, hypertension, heart disease, neurological disease or thyroid disease), and those who tested positive for hepatitis B, HIV or syphilis (associated with prematurity, intrauterine growth restriction (IUGR) and other neonatal morbidities which could influence neurodevelopment)
* Women who anticipate moving out of the city before/ after delivery (follow-up difficult/not possible, 16% delivered outside Sitaram Bhartia Institute of Science \& Research (SBISR) in earlier work done by Principle Investigator) (3)
* Women treated for infertility (higher risk of prematurity and neonatal complications
* Women with known pre-diagnosed mental health disorder including depression, drug or alcohol abuse likely to affect participation in the study
* Participation in another study within 4 weeks prior to trial start
* Allergy to B12 or another supplement constituent
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT03783104
Study Brief:
Protocol Section:
NCT03783104