Vitamin B12 Dose Escalation Trial in Pregnancy

Phase 1

Active, not recruiting

• Conditions: Vitamin B 12 Deficiency
• Interventions: Drug: Vitamin B12 10 µg; Drug: Vitamin B12 2.6 µg; Drug: Vitamin B12 50 µg

• Registration Number: NCT05426395
• Lead Sponsor: George Washington University

Brief Summary

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 four 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Study Start: 2023-06-05
• Primary Completion: 2024-01-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 2 (10 µg)	Vitamin B12 10 µg	Adding Vitamin B12 at a dose of 10 µg
Dose 1 (2.6 µg)	Vitamin B12 2.6 µg	Adding Vitamin B12 at a dose of 2.6 µg
Dose 3 (50 µg)	Vitamin B12 50 µg	Adding Vitamin B12 at a dose of 50 µg

Primary Outcome Measures

Name	Time	Method
Assessing the steady state pharmacokinetics of B12 upon oral administration in pregnant women.	Over 4 weeks	The sampling of the ratio of serum B12 to holotranscobalamin measured over 4 weeks at multiple occasions will be used to evaluate the absorption and disposition of B12. The mean change from baseline steady state B12 levels in pregnant women will be calculated for the three dose cohorts and the magnitude of difference (fold-change) in mean change from baseline steady state B12 levels between doses will be descriptively compared. Additionally, proportion of subjects who achieved or maintained sufficient B12 status will be assessed for each of the three dose cohorts. A dose with a higher fold difference (from 2.6ug) and higher proportion of women on sufficient status will be identified as a priority B12 dose regimen. The investigators will use metabolomics, proteomics, and genomics to identify novel biomarkers that can more robustly and sensitively reflect vitamin B12 status than conventional markers.

Secondary Outcome Measures

Name	Time	Method
Assessing hematological response: hemoglobin	On Day 29
Assessing hematological response: mean cell volume	On Day 29
Assessing serum methylmalonic acid (MMA)	On Day 29
Assessing serum and urinary homocysteine	On Day 29
Assessing hematological response: hematocrit	On Day 29
Assessing hematological response: erythrocyte count	On Day 29
Assessing hematological response: reticulocyte number	On Day 29

Trial Locations

Locations (1)

Ifakara Health Institute Bagamoyo Clinical Trial Unit (BCTU); 🇹🇿 Bagamoyo, Tanzania