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Vitamin B12 Dose Escalation Trial in Pregnancy

Study acronym: MM4MN-B12
StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Study completion date: Dec 2025 to Dec 2026v10
  2. Study completion date: Dec 2024 to Dec 2025v9
  3. Study completion date: May 2024 to Dec 2024v8
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2023 to Jan 15, 2024
    • Study completion date: Dec 2023 to May 2024
    • Site details revised
    v7
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: May 2023 to Dec 2023
    • Start date changed from estimate of Mar 1, 2023 to Jun 5, 2023
    • Site details revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary endpoints revised (3)
    • Secondary endpoints: 10 to 7
    v5
  2. Start date: Dec 2022 to Mar 1, 2023v4
  3. Start date: Aug 1, 2022 to Dec 2022
    • Primary and study completion dates: Dec 2022 to May 2023
    v3
  4. Start date: Jun 30, 2022 to Aug 1, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05426395
Lead Sponsor George Washington University
Collaborators: Ifakara Health Institute
Conditions
(from sponsor)		 Vitamin B 12 Deficiency
Related terms Vitamin B 12 Deficiency
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov