Randomized Trial of Vitamin B12 in Pregnant Indian Women

What Was Tested

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

Secondary aims for this trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight.

All women will receive standard of prenatal obstetric care, including routine supplementation with iron and folate.

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

Vitamin B12.

Placebo.

The registry classes the interventions as dietary supplement and other.

More on the Plan

In a prospective cohort study of 410 pregnant Indian women, the researchers recently found a strong relationship between maternal serum vitamin B12 concentration and risk of infant intrauterine growth retardation (IUGR).

Secondary aims for this exploratory trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight.

Who Took Part

Enrollment: 366 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Pregnant women at or before 14 weeks gestational age.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: women who anticipate moving outside of the study area before study completion; those with twin or multiple pregnancies; those who test positive for hepatitis b (hepbsag), hiv or syphilis (vdrl).

How the Study Was Run

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

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

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

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, care provider, investigator and outcomes assessor.

It started in 2008-12 with completion listed for 2011-01.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (time frame: from 1st to 3rd trimester).

It also tracked 11 secondary outcomes, for example Cognitive Scale, Bayley Scales of Infant Development, 3rd Edition, Receptive Language Scale, Bayley Scales of Infant Development, 3rd Edition, Expressive Language Scale, Bayley Scales of Infant Development, 3rd Edition, Fine Motor Scale, Bayley Scales of Infant Development, 3rd Edition, Gross Motor Scale, Bayley Scales of Infant Development, 3rd Edition and Kaufman's Assessment Battery for Children (KABC).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 366 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.