Quadruple Fortified Salt Trial in India

What Was Tested

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

Evidence supports the role of periconceptional nutrition in the development of neural tube defects and other pregnancy complications.

Vitamin B12 deficiency is a risk factor for neural tube defects and may modify folate biomarkers that predict neural tube defect risk at the population level.

It had four arms (groups): Quadruple-Fortified Salt (QFS) (experimental), DFS + Folic acid (experimental), DFS + Vitamin B12 (experimental) and Double-fortified salt (DFS) (active comparator).

Salt fortified with iron, iodine, folic acid, and vitamin B12.

Salt fortified with iron, iodine, and folic acid.

Salt fortified with iron, iodine, and vitamin B12.

The registry classes the interventions as other.

More on the Plan

Deficiencies in folate and/or vitamin B12 also result in megaloblastic anemia, and inadequate periconceptional folate and vitamin B12 status have been linked to pregnancy complications, including birth defects.

Neural tube defects are among the most common and debilitating birth defects in the United States and globally.

Neural tube defects are structural birth defects that arise when the neural folds fail to fuse entirely during early embryogenesis.

It is estimated that there are over 260,000 cases of neural tube defects per year globally, ranging from 1 to 80 per 10,000 births, with higher prevalence in low- and middle-income countries.

Who Took Part

The registry lists 1000 planned participants were the target.

It was open to women only aged from 18 years up to 49 years.

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

Examples of who could join: Women between 18 and 49 years of age. Not pregnant or lactating. Plan to reside in the catchment area of their periconceptional surveillance program for at least two years.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: stage 2 hypertension (sbp≥140 mm hg or dbp≥90 mm hg); daily micronutrient supplements (i.e., tablets, capsules, dispersible tablets; ≥4 times in the past week); intramuscular or intravenous interventions containing medications or micronutrients (e.g., iron, vitamin b12, folic acid) in the past 3 months.

How the Study Was Run

It was run as a randomized, factorial and triple-blind study.

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

Neither the anemia 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, investigator and outcomes assessor.

It started in 2023-10-01 with completion listed for 2024-12.

It ran at 1 site in India.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Concentrations of erythrocyte folate and serum folate (time frame: Endpoint (12 months)). Concentrations of hemoglobin (time frame: Endpoint (12 months)). Concentrations of vitamin B12 (time frame: Endpoint (12 months)).

It also tracked 3 secondary outcomes, for example Folate deficiency and insufficiency, Anemia and Vitamin B12 deficiency and insufficiency.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 1000 people with anemia.

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

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, Anemia research.