What's the best vitamin B12 dose for pregnancy? new study aims to find out

NCT ID NCT05426395

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests three different daily doses of vitamin B12 (2.6, 10, and 50 micrograms) in 40 pregnant women and 10 non-pregnant women in Tanzania. The goal is to see how the body processes B12 during pregnancy and find the optimal dose for future larger trials. Participants take the supplement for four weeks, and researchers measure B12 levels in the blood to determine the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vitamin B12
What this could lead to
If successful, this study could identify the best vitamin B12 dose for pregnant women, improving maternal and fetal health in areas where deficiency is common.
What could go wrong
This is a small, early-phase trial (50 participants) focused on dosing and biomarkers, not on health outcomes. The results may not apply to other populations or lead to immediate treatments.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

The inclusion criteria for pregnant women are as follows: * 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 The exclusion criteria for pregnant women are as follows: * 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. * Reports regular use of an over-the-counter, high dose vitamin B12 supplementation. (This criteria does not refer to normal prenatal vitamin supplements which typically include approximately 1 RDA of vitamin B12 or 2.6 ug of vitamin B12. Women using multiple micronutrient supplements, or MMS, are eligible for the study). * Reports cigarette smoking or tobacco chewing * Reports heavy alcohol use (\>3 drinks per day, or \>7 drinks per week) * Current malaria infection (per rapid diagnostic) * HIV/AIDS infection (due to potential interaction between first-line antiretroviral dolutegravir and multivitamins that has been shown to decrease dolutegravir exposure by about 33%). * Has a known allergy to corn or hydroxyethyl starch (HES). The inclusion criteria for non-pregnant women are as follows: * 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 The exclusion criteria for non-pregnant women are as follows: * Has severe anemia (hemoglobin \<8 g/dL) * Has Body Mass Index ≥ 35 kg/m2 * Has a self-reported diagnosis of type II diabetes mellitus, hypertension, or hypercholesterolemia. * 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. Any woman with clinical signs of liver disease will be given a liver function test including: ALT, AST (26,27). Those with liver disease will be excluded from the study and referred for treatment. * Has currently diagnosed congestive heart failure. * 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. * Reports regular use of an over-the-counter, high dose vitamin B12 supplementation. * Reports cigarette smoking or tobacco chewing * Reports heavy alcohol use (\>3 drinks per day, or \>7 drinks per week) * Current malaria infection (per rapid diagnostic) * HIV/AIDS infection (due to potential interaction between first-line antiretroviral dolutegravir and multivitamins that has been shown to decrease dolutegravir exposure by about 33%). * Has a known allergy to corn or hydroxyethyl starch (HES).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ifakara Health Institute Bagamoyo Clinical Trial Unit (BCTU)

    Bagamoyo, Tanzania

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Other studies related to the condition(s) this trial covers.