Vitamin B12 is a cofactor for 2 enzymes that have essential functions in pregnancy, both for
maternal health and for fetal development. However, there is currently limited data regarding
the metabolic fate and optimal dose of supplemental vitamin B12 and its relationship to
vitamin B12 status in pregnancy.
This is a single-blinded, stratified, dose-ranging trial of maternal vitamin B12
supplementation during pregnancy that will be conducted at the Ifakara Health Institute
Bagamoyo Clinical Trial Unit in Tanzania. The investigators will enroll 40 pregnant women
(gestational age 25-28 weeks) and 10 non-pregnant women (comparison group). Participants will
be blinded to dosing (2.6, 10, and 50 µg) and supplementation will be given for six weeks.
With this trial, the investigators aim to enhance our understanding of vitamin B12
bioavailability during pregnancy in people with sufficient and insufficient baseline B12
status, identify priority dose regimens of vitamin B12 in pregnancy for investigation in
later phase clinical trials to be conducted in populations where vitamin B12 insufficiency or
deficiency is common, and identify biomarkers of vitamin B12 intake appropriate for
pregnancy.
Phase:
Phase 1
Details
Lead Sponsor:
George Washington University
Collaborator:
Ifakara Health Institute
Treatments:
Hydroxocobalamin Vitamin B 12 Vitamin B Complex Vitamins