Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls

What Was Tested

The trial (phase 2) is built around Cyanocobalamin (Vitamin B12).

Adolescent anaemic girls will be randomly divided into two groups. * Group 1: IFA weekly supplementation along with Information, Education, Communication sessions * Group 2: IFA + Cyanocobalamin weekly supplementation along with Information, Education, Communication sessions Duration of supplementation: 6 months.

It had two arms (groups): Iron and Folic Acid (active comparator) and Iron, Folic acid and cyanocobalamin (experimental).

The registry classes the interventions as drug.

More on the Plan

Anaemic adolescent girls (n=360) will be randomly divided into two groups.

Anthropometric measurements and dietary information will be collected besides biochemical analysis.

Who Took Part

Enrollment: 360 planned participants were the target.

It was open to women only aged from 11 years up to 18 years.

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

Examples of who could join: Willingness to participate. Unmarried or married (who still reside with their parents, i.e. prior to 'Gauna') adolescent girl.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: severe anaemia; pregnant adolescent girls.

How the Study Was Run

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

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant and investigator.

It started in 2012-01 with completion listed for 2012-11.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in hemoglobin level (time frame: at baseline and after 6 months).

It also tracked 1 secondary outcome, for example Change in serum ferritin, folic acid and vitamin B12 levels.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 360 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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