Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

Vitamin B12 is an essential nutrient that the body needs for cells to divide and function normally.

Keeping adequate B12 blood levels is important for health.

It had 1 arm (groups): Vitamin B12 supplement (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

All participants will sign informed consent forms approved by the UF Institutional Review Board prior to the initiation of this part of the study.

Subjects' heights and weights will be measured and subjects will be asked to complete a medical history questionnaire.

Blood analyses will include serum B12, blood chemistry, and hematological indices.

Females will be given a pregnancy test.

Who Took Part

21 actual participants took part.

It was open to people of any sex aged from 18 years up to 49 years.

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

Examples of who could join: No vitamin B12-containing supplement use within past year. No vitamin B12 injections within past year. No use of tobacco products. No chronic use of prescription medications except oral contraceptives. No history of chronic disease (e.g., pernicious anemia, cancer, diabetes, renal disease, hypertension, neurological abnormalities, gastrointestinal disorders).

The full record lists 10 inclusion and 11 exclusion criteria; among the exclusions: vitamin b12 supplement use or injections within past year; pregnant or breast feeding; has bmi \<18.5 or \>29.9.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-10 with completion listed for 2005-11.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Change in Holo-transcobalamin (time frame: Holo-transcobalamin measured at 24 hours after baseline).

It also tracked 1 secondary outcome, for example Total Transcobalamin Measured at Intervals From Baseline to 48 Hours.

What This Means in Plain Language

Put simply, this is a not phased trial of Cyanocobalamin (Vitamin B12) in 21 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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