article · Gates Open Research
Vitamin B12 is essential for maternal health and foetal development, yet the ideal supplemental dosage during pregnancy remains unclear due to limited evidence. A clinical trial protocol in Bagamoyo, Tanzania, outlines a single-blinded, stratified, dose-ranging study designed to assess vitamin B12 pharmacokinetics. The trial plans to enrol 40 pregnant individuals at 25 to 28 weeks of gestation alongside 10 non-pregnant participants, stratified by their baseline B12 status. Over a four-week in-patient period featuring controlled feeding and daily monitoring, pregnant participants receive 2.6, 10, or 50 micrograms daily, with the highest dose split into once-daily or twice-daily regimens. Non-pregnant participants receive 2.6 micrograms daily. Primary outcomes focus on changes in serum B12 and holotranscobalamin levels to determine how dosage and baseline status affect absorption and steady-state concentrations.
Proper maternal nutrition is critical for healthy pregnancies and fetal growth. Because clear evidence on effective vitamin B12 dosing during pregnancy is lacking, this study aims to supply accurate pharmacological data. Understanding how different doses are absorbed under controlled conditions can help refine nutritional recommendations and inform clinical guidance for maternal care.
This trial protocol represents early-stage clinical research aimed at establishing pharmacokinetic baselines. While it does not deliver an immediate commercial product, the findings could ultimately inform pharmaceutical companies and nutritional supplement manufacturers in formulating evidence-based maternal multivitamins and targeted dosing regimens for pregnant populations.
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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: 10.12688/gatesopenres.15991.2
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