The administration of vitamin B12 to people with type 2 diabetes (T2DM) on long term metformin therapy

The effect of oral vitamin B12 supplementation vs intramuscular injection on serum vitamin B12 level in people with type 2 diabetes on metformin therapy

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001108808

Enrollment

Registered

2012-10-17

Start date

2013-02-15

Completion date

2014-02-04

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Metformin, the most common hypoglycaemic agent used in type 2 diabetes, is associated with reduced vitamin B12 status. This study will determine the prevalence of B12 deficiency (<150pmol/l) and low B12 status (150-220 pmol/l) in a NZ population with Type 2 Diabetes taking metformin. We will then assess the best replacement regimen in this group. Those with low or deficient B12 status will be randomised to either intra-muscular injection OR over the counter oral B12 tablets. B12 status will be assessed at 3 and 6 months, with a second treatment administered if levels have not returned to normal after the 3 month check.

Interventions

Methylcobalamin 1000mcg tablets 3 month course of 1 x 1000mcg tablet per day. Rescreen at 3 months, if levels not above 220 mmol/l then re-treat with the same treatment.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Type 2 diabetes Metformin therapy vitamin b12 levels below 220mmol/l

Exclusion criteria

Pregnant or breastfeeding Existing treated megaloblastic anaemia

Outcome results