The Absorption of Vitamin B12 Among Healthy Pregnant Women

What Was Tested

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

Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy.

In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12.

It had 1 arm (groups): A (other).

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 27 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: The 13 week of gestation +/- 1 week (only fore pregnant women). Between 20- 40 years. Abel to read and understand danish.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: treatment with vitamin b12 within the last 5 years; infectious disease; systemic disease.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

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

It started in 2008-08 with completion listed for 2009-07.

It ran at 1 site in Denmark.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Change in vitamin B12 absorption during pregnancy, measured with CobaSorb (time frame: 9 month).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cyanocobalamin (Vitamin B12) in 27 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.