Status:
COMPLETED
Vitamin B12 Supplementation to Improve B12 Status and Child Development
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
University of California, Davis
Nestlé Foundation
Conditions:
Early Pregnancy
Eligibility:
All Genders
18-35 years
Phase:
NA
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...
Detailed Description
The investigators aim to conduct a double-blind, randomized trial, to investigate the effects of B12-fortified milk on maternal and infant B12 status, immune function and child development. Pregnant w...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT03258385
Start Date
September 1 2017
End Date
October 30 2021
Last Update
January 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maternal and Child Health Training Institute
Dhaka, Bangladesh, 1205