Vitamin B12 Supplementation Study

What Was Tested

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

The researchers hope to learn the clinical and functional signs of sub-clinical vitamin B12 deficiency and its response to supplementation in non-anemic, non-pregnant, and non-lactating women in Rural Mexico.

Vitamin B12 is important in hematopoiesis, neuro-cognitive functions and genetic integrity.

However vitamin B12 is only found in animal source foods therefore a large segment of the population in developing countries and those practicing vegetarianism are at risk of deficiency of the vitamin.

It had two arms (groups): placebo (placebo comparator) and Vitamin B12 (active comparator).

The registry classes the interventions as dietary supplement.

Who Took Part

180 actual participants took part.

It was open to women only aged from 20 years up to 59 years.

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

Examples of who could join: Women age 20-59, apparently healthy, no severe B12 deficiency.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: pregnancy, lactation, anemia and disease states.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

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

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2004-10 with completion listed for 2005-08.

It ran at 1 site in Mexico.

Its stated primary purpose is health services research.

What Was Measured

The main thing measured (primary outcome): response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations (time frame: 0 and 3 mos).

It also tracked 1 secondary outcome, for example DNA methylation change, and hematological response to B12 supplementation.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 180 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.