Effect of Folic Acid and Vitamin B12 Supplementation in Subjects With Type 2 Diabetes

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

The biochemical parameters will be evaluated before and after the intervention.

It had four arms (groups): Folic acid (experimental), Vitamin B12 (experimental), "Folic acid" and "Vitamin B12" (experimental) and Control (active comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

All the subjects will be asked to report after an overnight fasting of 12 hours on two occasions i.e. at the start of the study before allocation of group and 8 weeks after allocation.

The samples collected will then be appropriately processed for the analysis of various biochemical parameters.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to people of any sex aged from 30 years up to 65 years.

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

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: subjects on non-allopathic forms of treatment for diabetic control; subjects with chronic renal disease and liver disease; subjects with malabsorption.

How the Study Was Run

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

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

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2017-05-01 with completion listed for 2017-08-15.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: 8 weeks).

It also tracked 13 secondary outcomes, for example Fasting plasma glucose, Fasting plasma insulin, Insulin Resistance, Serum total cholesterol, Serum triacylglycerol and Serum Low-density lipoprotein (LDL).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 80 people.

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.