Vitamin B12 Biomarker Responses to Supplementation

What Was Tested

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

Study design: A double-blind randomized controlled trial in healthy adults aged 18 years and over will be conducted.

It had four arms (groups): Folic Acid + Placebo (placebo comparator), one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

The sample size will be estimated by using typical variances from published studies on plasma homocysteine responses to vitamin B12 supplementation in adults.

The calculations are based on changes in plasma homocysteine, as it is considered a functional indicator of vitamin B12 status.

Those interested in the study will receive a participant information sheet and further details about the study.

A signed informed consent will be obtained from all who are willing to participate in the study.

Who Took Part

Enrollment: 200 actual participants took part.

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: Healthy volunteers aged 18 years and above who do not comply with the.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: history of gastrointestinal, hepatic, renal, vascular or haematological diseases, or diabetes;; use of medication known to interfere with b12 metabolism (e.g. methotrexate, proton pump inhibitor drugs);; use of b vitamin supplements;.

How the Study Was Run

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

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2004-10-01 with completion listed for 2006-12-12.

It ran at 1 site in United Kingdom.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Vitamin B12 biomarkers. Vitamin B12 biomarkers. Vitamin B12 biomarkers.

It also tracked 6 secondary outcomes, for example Folate status, MTHFR C677T polymorphism (rs1801133), Serum Pepsinogen concentrations, Plasma creatinine, BMI and Cognition.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 200 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.