Vitamin B12 Absorption Study

What Was Tested

In this phase 4 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

This randomized, double-blind, crossover trial (Phase IV) aims to compare the absorption of a novel permeability-enhanced oral vitamin B12 formulation (Ampli-B) versus standard oral vitamin B12 in 12 healthy adults aged 50 years and older.

The primary outcome is time to peak serum concentration (Tmax) of total and active vitamin B12 (holotranscobalamin).

It had two arms (groups): Ampli-B (experimental) and Standard B12 (active comparator).

The registry classes the interventions as dietary supplement.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

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

Examples of who could join: Males and females 50 years of age and older. BMI between 18 to 29.9 kg/m2. Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration). Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration). Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).

The full record lists 16 inclusion and 16 exclusion criteria; among the exclusions: individuals who are pregnant, breast feeding, or planning to become pregnant during the study; taking vitamin b12 supplements or a multivitamin supplement containing vitamin b12 within the prior 2 months from study product administration; current use of prescribed and/or over-the-counter (otc) medications, supplements, and/or consumption of food/drinks that may impact the absorption of vitamin b12.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Each person switched between Cyanocobalamin (Vitamin B12) and the comparison at some point, usually with a gap in between.

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 2026-07-20 with completion listed for 2026-08-21.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12 (time frame: Day 1 to 24hrs post Visit 3 (visit 4/day 11)).

It also tracked 10 secondary outcomes, for example Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 Cmax, Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal disposition rate constant, Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal half-life, Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin Cmax and Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin terminal half-life.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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