Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12) for anemia.

Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination.

A deficiency of either vitamin will predispose teenagers to many diseases, which persist across their lifespan.

It had two arms (groups): Control group (placebo comparator) and folic acid & vit B12 fortified flour (experimental).

Teenage girls randomly assigned to the control group will receive a standard bag of unfortified cereal flours every week for six months.

Teenage girls randomly assigned to the control group will receive a standard bag of cereal flours fortified with folic acid and Vit B12 every week for six months.

The registry classes the interventions as dietary supplement and other.

More on the Plan

Folic acid (FA) and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination.

Teenagers are the future mothers.

Hence their health and nutritional status have long term consequences on future pregnancies and birth outcomes.

Neural Tube Defects (NTDs) are a group of fatal or severely disabling birth defects known to be mainly a consequence of severe folate deficiency in early pregnancy.

Who Took Part

The registry lists 472 actual participants took part.

It was open to women only aged from 13 years up to 19 years.

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

Examples of who could join: One or both of their parents signed an informed consent form and the girl's agreement. Their parents and the girl planned to stay in the study area during the period of the study (minimum 6 months) in the kebele. Both parents and girls accept the intervention packages including blood draws and home visits.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: chronically ill girls diagnosed with diabetes and asthma;; severely undernourished girls (defined as body mass index z score \< -3 standard deviations of the median world health organization reference population);; teenage girls who are pregnant, lactating or taking ifa/b12 supplements;.

How the Study Was Run

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

The anemia participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

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

Blinding on both sides kept the anemia 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 2023-12-11 with completion listed for 2024-08-01.

It ran at 2 sites in Ethiopia (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Serum folic acid concentrations (time frame: Assessed at 6 months). Erythrocyte (RBC) folic acid concentrations (time frame: Assessed at 6 months). General cognitive ability (time frame: Assessed at 6 months).

It also tracked 9 secondary outcomes, for example RBC structure (megaloblastic anaemia), Plasma homocysteine concentrations, Weight, Adherence to the intervention/fortification, Haemoglobin concentration and Height.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 472 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.