A Study to See if a Combination of Vitamins That is Injected Into a Muscle is as Good and Safe as a Vitamin That is Taken by Mouth

What Was Tested

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

Safety objectives: To evaluate the safety and tolerability of oral vitamin B12 mono therapy versus intramuscular vitamin B12 combination.

1 injection twice weekly at the clinical site. Totally 8 injections through 4 week treatment period.

The registry classes the interventions as drug.

Who Took Part

46 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provision of written informed consent to participate in the study (according to Order of the Ministry of Health of Ukraine No. 690 (with amendments)). Female and male patients aged ≥18. Able to communicate well with the investigator and able to understand and comply with the requirements of the study. Patients are otherwise in relatively good health as determined by past medical history, physical examination, vital signs, and laboratory tests at screening (V -1).

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: participation in a previous clinical study with vitamin b12 within the 6 months prior to screening; any contraindication to one of the study drugs; pregnant or nursing (lactating) women.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

It started in 2025-04-16 with completion listed for 2025-10-07.

It ran at 2 sites in Ukraine (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Vitamin B12 (time frame: Change from baseline at day 28).

It also tracked 10 secondary outcomes, for example Holotranscobalamin, Homocystein, Methylmalonic acid, Combined vitamin B12 marker (cB12), Serum S-adenosylmethione (SAM) and Serum S-adenosylhomocysteine (SAH).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 46 people.

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.