Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients

What Was Tested

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

It had two arms (groups): Vitamin B12 and Antidiabetics (active comparator) and antidiabetics (no intervention).

Only regular antidiabetic drugs will be given.

The registry classes the interventions as dietary supplement.

More on the Plan

After approval from Institutional Ethics Committee, patients not responding adequately to oral anti-diabetic agents were recruited from Medicine out patient department (OPD) with the help of treating physician.

Patient were first screened for serum homocysteine/vitamin B12 level along with all baseline investigations.

Those having serum homocysteine level more than 15 umol/L or vitamin B12 level less than 223pg/ml were enrolled in this study.

Due to high cost for investigation serum homocysteine level was measured only in 6 patients and serum vitamin B12 level (cheaper test) was measured in 14 patients with prior permission from Ethics Committee.

Who Took Part

The registry lists 38 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Age between 30 -70 years. Sex: Male/ Non-lactating female. Glycosylated hemoglobin (HbA1c) \> 8. Serum Homocysteine \> 15 umol / L or vitamin B12 less than 223pg/ml.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: age \< 30 yrs; lactating mother; patient with insulin dependent diabetes mellitus.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-10 with completion listed for 2015-05.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To compare the change in HbA1c levels (%) with vitamin B12 supplementation in poorly controlled type 2 diabetic patients (time frame: baseline and 4 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 38 people.

Its size is small, so on its own it can only give an early look.

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.