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Vitamin B12 is essential for maternal health and fetal development, yet the optimal supplemental dose during pregnancy is not well understood. A clinical trial protocol in Bagamoyo, Tanzania, outlines a single-blinded, stratified, dose-ranging study involving 40 pregnant and 10 non-pregnant participants. Participants are categorised by their baseline vitamin B12 levels. Pregnant individuals receive doses of 2.6, 10, or 50 micrograms daily over four weeks, with the highest dose evaluated as either a single daily administration or split into two doses. Non-pregnant participants receive 2.6 micrograms daily. Conducted as a controlled feeding study with a four-week in-patient phase, the trial measures serum vitamin B12, holotranscobalamin levels, and their ratio to evaluate saturable absorption and steady-state kinetics.
Proper nutrition during pregnancy is vital for both mothers and developing babies. Because clear evidence on the ideal daily amount of vitamin B12 is lacking, this study aims to provide precise data on how the body absorbs and maintains this nutrient at different doses. This can help inform better nutritional guidelines and prenatal care strategies.
This work represents early-stage clinical research establishing nutritional and pharmacokinetic baselines. While it does not present an immediate commercial product, the resulting data could inform pharmaceutical companies, supplement manufacturers, and public health agencies developing targeted prenatal micronutrient formulations. The abstract does not indicate an immediate commercialisation pathway beyond clinical trial evaluation.
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Background Vitamin B12 is an essential cofactor for two enzymes that have critical functions in pregnancy, both for maternal health and fetal development. However, the optimal supplemental dosage and its correlation with vitamin B12 status during pregnancy remain inadequately understood due to limited data. Methods This is a single-blinded, stratified, dose-ranging trial of vitamin B12 supplementation that will be conducted at the Ifakara Health Institute Bagamoyo Clinical Trial Unit in Bagamoyo, Tanzania. We will enroll 40 pregnant participants (gestational age 25–28 weeks) and 10 non-pregnant participants, stratified based on baseline vitamin B12 status (sufficient and insufficient). Pregnant participants are sequentially assigned to one of three doses: 2.6, 10, and 50 µg for four weeks. At the highest dose, pregnant participants are randomized to receive 50 µg once a day (Q24H) or 25 µg twice a day (Q12H). The two lower doses (2.6 and 10 µg) are given Q24H. Non-pregnant participants will receive 2.6 µg Q24H. The trial includes a four week in-patient phase for daily assessment and controlled feeding, with pregnant participants assessed once postpartum. Primary endpoints include serum B12 concentrations, holotranscobalamin concentrations, and their ratio after four weeks of daily supplementation. Discussion This study aims to deepen our understanding of nutrient requirements in pregnancy by generating high-quality, high dimensional data. We will answer questions about how pre supplementation vitamin B12 status and dosage impact vitamin B12 saturable absorption and steady-state over the course of four weeks. Limitations include our inability to assess pharmacokinetic changes across gestation, the impact of vitamin B12 status or supplementation on pregnancy and fetal/newborn health, comparing vitamin B12 effects between pregnant and non-pregnant individuals above the recommended dietary allowance (2.6 µg), and comparing Q12H and Q24H dosing at 50 µg. This is the first controlled feeding study to be conducted in sub-Saharan Africa. Registration ClinicalTrials.gov ( NCT05426395 , 16/06/2022).
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DOI: 10.21956/gatesopenres.17759.r39860
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