Folic Acid and Vitamin B12 in Young Indian Children

What Was Tested

In this phase 2 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

Children aged 6-30 months will be identified through a survey.

It had four arms (groups): A (placebo comparator), B (experimental), C (experimental) and D (experimental).

Placebo dietary supplement.

Folic acid.

Vitamin B12.

The registry classes the interventions as dietary supplement.

More on the Plan

Many of these children have inadequate intakes of several vitamins and minerals.

Folate and vitamin B12 are important for normal function of the immune system.

Deficiencies of these vitamins are often part of general malnutrition and might be responsible for the excess morbidity and mortality seen in malnourished children.

Who Took Part

The registry lists 1000 actual participants took part.

It was open to people of any sex aged from 6 months up to 30 months.

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

Examples of who could join: Age: 6 to 30 months. Likely to reside in area for next 6 months.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: severe systemic illness requiring hospitalization; non consent; consuming vitamin supplements that include folic acid and vitamin b12.

How the Study Was Run

It was run as a randomized, factorial and quadruple-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.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-01 with completion listed for 2011-09.

It ran at 1 site in India.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia) (time frame: 6 months). Prevalence of diarrhea (time frame: 6 months).

It also tracked 10 secondary outcomes, for example Growth (length for age, weight for age, and length for weight), Adverse events (vomiting and gastric discomfort), Changes in folate, vitamin B12, methyl malonic acid, and homocysteine concentration, Developmental Milestones, Measure the association between pneumonia incidence and the plasma mannose binding lectin (MBL) concentration and Measure the exposure to Cryptosporidium spp.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 1000 people.

With 1000 participants it is a large trial for this field.

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.