Oral Cyanocobalamin (Eligen B12) Bioavailability Study

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

The safety and tolerability of oral Eligen® B12 (cyanocobalamin/SNAC) versus oral cyanocobalamin alone and versus IV cyanocobalamin are also assessed.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

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

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

Examples of who could join: Healthy male subjects aged 18 to 45 years. Signed ICF prior to any study-related procedures. Normal organ function including renal and hepatic function. Normal hematological function. Body weight between 60 and 100 kg and within 18 - 30 kg/m2 for body mass index (BMI).

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: current use (within 14 days) of acetaminophen or non-steroidal anti-inflammatory drugs (nsaids) (i.e., aspirin or ibuprofen); current use (within 14 days) of antibiotics, antacids, multivitamins, or nutritional supplements; absolute platelet count below 100 x 109/l.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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.

It started in 2008-05 with completion listed for 2008-06.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Number of Subjects with Adverse Events as a Measure of Safety and Tolerability.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 20 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.