Status:
UNKNOWN
Maternal B12 Supplementation to Improve Infant B12 Deficiency and Neurodevelopment
Lead Sponsor:
University College, London
Collaborating Sponsors:
Sitaram Bhartia Institute of Science and Research
Paropakar Maternity and Women's Hospital
Conditions:
Child Developmental Delay
Child Malnutrition
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
Vitamin B12 plays a key role in the development and normal functioning of the brain and nervous system. Unborn and new-born infants derive their vitamin B12 stores almost entirely from maternal B12 st...
Detailed Description
The project is a multi-centric, double-blind and parallel two-armed randomised controlled trial divided into two stages: Stage 1: A total of 720 recruited mothers across India and Nepal will be rand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT03783104
Start Date
April 27 2019
End Date
December 1 2021
Last Update
July 22 2019
Active Locations (2)
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1
Sitaram Bhartia Institute for Science and Research
New Delhi, India, 110016
2
Paropakar Maternity and Women's Hospital
Kathmandu, Nepal, 44600