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Effect of Methylcobalamin and Cyanocobalamin Consumption on Vitamin B12 Nutritional Status

Plain-language guide to NCT05785585: not phased randomized trial of Cyanocobalamin (Vitamin B12), 54 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05785585
Phase
not phased
Status
recruiting participants
Start
2023-09-09
Completion (planned or actual)
2025-09
Participants
54 (estimated)
Design
randomized, quadruple-blind, prevention
Conditions studied
Vitamin B12 Nutritional Deficiency
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

Vitamin B12 (B12, Cobalamin) is an essential micronutrient that humans are not capable of synthesizing and therefore must be ingested through food.

In nature, B12 is basically only present in foods of animal origin.

It had three arms (groups): Methylcobalamin group (experimental), Cyanocobalamin group (active comparator) and Control group (placebo comparator).

One capsule daily with microcrystalline cellulose for 12 weeks.

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 54 planned participants were the target.

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

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

Examples of who could join: Men and women aged 18 years or older who follow a vegetarian diet. Sign the informed consent. Read, write and speak Catalan or Spanish.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: medical history of abdominal surgery that may influence the absorption of vitamin b12 (such as bariatric surgery); being on hemodialysis treatment; present values of body mass index ≤ 18.5 kg/m\^2 or ≥ 35 kg/m\^2.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

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 2023-09-09 with completion listed for 2025-09.

It ran at 2 sites in Spain (2).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Levels of total vitamin B12 in blood.

It also tracked 20 secondary outcomes, for example Levels of Holotranscobalamin in blood, Levels of Methylmalonic acid in blood, Levels of Homocysteine in blood, Levels of 4cB12 marker, Levels of folate in blood and Levels of vitamin B6 in blood.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 54 people.

It is still 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.

Our Notes on the Compound

Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.