Vitamin B12 Dose Escalation Trial in Pregnancy

What Was Tested

The trial (phase 1) is built around Cyanocobalamin (Vitamin B12).

It had three arms (groups): one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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 full record lists 5 inclusion and 32 exclusion criteria; among the exclusions: known multiple pregnancy (e.g. twins, triplets); 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-06-05 with completion listed for 2024-01-15.

It ran at 1 site in Tanzania.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 7 secondary outcomes, for example Assessing serum methylmalonic acid (MMA), Assessing serum and urinary homocysteine, Assessing hematological response: hemoglobin, Assessing hematological response: hematocrit, Assessing hematological response: erythrocyte count and Assessing hematological response: mean cell volume.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cyanocobalamin (Vitamin B12) in 50 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.