Vitamin B12 Dose Escalation Trial in Pregnancy

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 5, 2023

Primary Completion Date

January 15, 2024

Study Completion Date

December 31, 2025

Conditions
Vitamin B 12 Deficiency
Interventions
DRUG

Vitamin B12 2.6 µg

There are four groups of women (n = 20 total) who will receive B12 dosing once daily, including group 1a (sufficient baseline B12, pregnant), group 1b (sufficient baseline B12, non-pregnant), group 1c (insufficient baseline B12, pregnant), and group 1d (insufficient baseline B12, non-pregnant).

DRUG

Vitamin B12 10 µg

There are two groups of women (n = 10 total) who will receive B12 dosing once daily, including group 2a (sufficient baseline B12, pregnant) and group 2b (insufficient baseline B12, pregnant).

DRUG

Vitamin B12 50 µg

The participants (n = 20 total) will be randomly assigned to receive either a once per day B12 dose or a twice per day B12 dose. The four groups at this dose level include: group 3a (sufficient baseline B12, pregnant, Q12), group 3b (sufficient baseline B12, Q24), group 3c (insufficient baseline B12, pregnant, Q12), group 3d (insufficient baseline B12, Q24).

Trial Locations (1)

Unknown

Ifakara Health Institute Bagamoyo Clinical Trial Unit (BCTU), Bagamoyo

All Listed Sponsors
collaborator

Ifakara Health Institute

OTHER

lead

George Washington University

OTHER