Vitamin B12 Pregnancy Supplementation

What Was Tested

This registered phase 4 trial tested Cyanocobalamin (Vitamin B12) for anemia.

It had two arms (groups): Receiving treatment (active comparator) and Control group (no intervention).

Standard prenatal care (custom folic acid therapy and iron supplements).

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 200 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Healthy women from 8th week of pregnancy.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: existence of hypertension; existence of diabetes; existence of genetic abnormalities.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind 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.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

In this single-blind Cyanocobalamin (Vitamin B12) study one party knew the assignments and the other did not.

Those kept unaware of assignments: care provider.

It started in 2011-09-15 with completion listed for 2012-12-23.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Change of Red blood cells (RBC) count in first and second trimester (time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy). Change of Hemoglobin (Hgb) concentration in first and second trimester (time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy). Change of Hematocrit in first and second trimester (time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy).

It also tracked 8 secondary outcomes, for example Change of White Blood Cells (WBC) in first and second trimester, Change of Platelet Count in first and second trimester, Change of Transferrin in first and second trimester, Change of Neutrophils in first and second trimester, Change of Lymphocytes in first and second trimester and Change of Monocytes in first and second trimester.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 200 people with anemia.

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, Anemia research.