Vitamin B12 Supplementation During Pregnancy

What Was Tested

This registered phase 2, phase 3 trial tested Cyanocobalamin (Vitamin B12) for anemia.

Nutritional anemia is a major public health problem among children and women in developing countries.

Vitamin B12 deficiency is a more prevalent cause of megaloblastic anemia than folate in many developing countries.

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

The registry classes the interventions as dietary supplement.

More on the Plan

Study Area: A maternity clinic in Mirpur with substantial numbers of pregnant women enrolling each month (about 300-400/month) will be selected for recruitment of local pregnant women.

The community in Mirpur has a low out-migration rate.

Study Population: Pregnant women (n=120) will be screened during 11-14 weeks of gestation.

Infants (n=120) at 3 months of age.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to people of any sex aged from 22 years up to 35 years.

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

Examples of who could join: Age: 22-35 years. Mothers at the beginning of second trimester (i.e. at 11-14 weeks of gestation). Willing to stay in Dhaka during pregnancy and willing to get admitted in the clinic for delivery. Self-reported Last Menstrual Period (LMP) and urine pregnancy test will be used to determine the gestational age.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: H/O of previous complicated pregnancies or of pre-term delivery, abortion; receipt of influenza vaccine.

How the Study Was Run

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

The anemia 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 anemia 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 investigator.

It started in 2010-02 with completion listed for 2012-06.

It ran at 1 site in Bangladesh.

Its stated primary purpose is health services research.

What Was Measured

It also tracked 2 secondary outcomes, for example Effect of B12 status on DNA methylation and one-carbon metabolism in mother-child pairs.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 120 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.