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Vitamin B12 Dose Escalation Trial in Pregnancy | Clinical Trials | Clareo Health

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Vitamin B12 Dose Escalation Trial in Pregnancy

Single-blinded, Stratified, Multiple Ascending Dose Trial to Assess Pharmacokinetics and Identify Optimal Dose of Vitamin B12 in Pregnancy in Tanzania

NCT05426395•George Washington University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Pregnant female
•Has an estimated gestational age of 25 to 28 weeks at study initiation
•Is between the ages of 18 and 45 years of age
•Lives in the study area and does not plan to travel outside of the study area for the duration of the trial
•Consents to participate in the trial
•Is between the ages of 18 and 45 years of age.
•Lives in the study area and does not plan to travel outside of the study area for the duration of the trial
•Consents to participate in the trial

Exclusion Criteria

•Known multiple pregnancy (e.g. twins, triplets)
•Has severe anemia (hemoglobin \<7 g/dL)
•Has pre-pregnancy or early pregnancy Body Mass Index ≥ 35 kg/m2
•Has a self-reported pre-pregnancy history of type II diabetes mellitus, hypertension, or hypercholesterolemia.
•Has currently diagnosed preeclampsia or eclampsia.
•Has currently diagnosed gestational diabetes.
•Has currently diagnosed renal, liver, autoimmune, or bleeding disorders. The investigators will also assess all women for clinical signs of liver disease including: jaundice or yellowing of skin/sclera/mucosa, right upper quadrant tenderness or pain. All women will be given a liver function test, regardless of clinical signs of liver disease. The tests include: serum Alanine aminotransferase (ALT) and serum Aspartate aminotransferase (AST). Abnormal liver function is defined as the following in this study for women who the investigators screened during the 2nd trimester (25-26 weeks), ALT below 2 or above 33 U/L, or AST below 3 or above 33 U/L; for women screened during the 3rd trimester (27-28 weeks), ALT below 2 or above 25 U/L, or AST below 4 or above 32 U/L (25). Those with liver disease or abnormal liver function will be excluded from the study and referred for treatment.
•Has currently diagnosed congestive heart failure. The investigators will first look for clinical signs of heart failure, and the investigators will focus on the following: i) Fatigue with limitation in performance of normal activities; ii) Coughing, wheezing and breathing difficulty because of lung congestion; iii) Swelling of ankles, feet and legs; and iv) Shortness of breath especially when lying flat. The investigators will only perform lab testing for those who have clinical manifestation, and refer them to appropriate and timely care.
•Has a history of significant gastrointestinal surgeries, such as bariatric surgery, cholecystectomy, or other surgical procedures affecting the stomach, liver, bile ducts and/or small intestine that may disrupt enterohepatic recycling of vitamin B12.
•Has a condition requiring the use of the following medications: H2 blockers, proton pump inhibitors, or prokinetic agents.
+19 more criteria

Locations (1)

Ifakara Health Institute Bagamoyo Clinical Trial Unit (BCTU)

Bagamoyo, Tanzania

Key Dates

Start Date

June 5, 2023

Primary Completion Date

January 15, 2024

Completion Date

December 1, 2026

Last Updated

February 5, 2026

Enrollment

ACTUAL participants

Conditions

Vitamin B 12 Deficiency

Interventions

Vitamin B12 2.6 µg

DRUG

Vitamin B12 10 µg

DRUG

Vitamin B12 50 µg

DRUG

Early Infant Micronutrition and Development

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Vitamin B12 Dose Escalation Trial in Pregnancy

Inclusion Criteria

Exclusion Criteria

Early Infant Micronutrition and Development

Quadruple Fortified Salt Trial in India

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