Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001108808
Ethics application status
Approved
Date submitted
12/10/2012
Date registered
17/10/2012
Date last updated
5/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The administration of vitamin B12 to people with type 2 diabetes (T2DM) on long term metformin therapy
Scientific title
The effect of oral vitamin B12 supplementation vs intramuscular injection on serum vitamin B12 level in people with type 2 diabetes on metformin therapy
Secondary ID [1] 281384 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 287616 0
Vitamin B12 deficiency 287617 0
Condition category
Condition code
Metabolic and Endocrine 287946 287946 0 0
Diabetes
Diet and Nutrition 287982 287982 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285859 0
Treatment: Other
Comparator / control treatment
1 x 1000mcg methylcobalamin intramuscular injection - current standard treatment. Rescreen at 3 months, if levels not above 220 mmol/l then re-treat with the same treatment.
Control group
Active

Outcomes
Primary outcome [1] 288155 0
serum vitamin B12 level
Timepoint [1] 288155 0
3 and 6 months
Secondary outcome [1] 299523 0
neuropathy screening using Michigan neuropathy screening questionnaire
Timepoint [1] 299523 0
6 months

Eligibility
Key inclusion criteria
Type 2 diabetes
Metformin therapy
vitamin b12 levels below 220mmol/l
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breastfeeding
Existing treated megaloblastic anaemia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be stratified by B12 level to ensure an even number of those with low and deficient status in each group, then randomised by sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation numbers will be computer generated by a random numbers progamme and placed in sealed envelopes. The next envelope on the pile will be given sequentially to participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2013
Actual
15/02/2013
Date of last participant enrolment
Anticipated
Actual
4/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 4597 0
New Zealand
State/province [1] 4597 0
Wellington

Funding & Sponsors
Funding source category [1] 286136 0
University
Name [1] 286136 0
University of Otago
Country [1] 286136 0
New Zealand
Primary sponsor type
Hospital
Name
Capital and Coast Health
Address
Private bag 7902
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 284947 0
None
Name [1] 284947 0
Address [1] 284947 0
Country [1] 284947 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288188 0
Health and Disability Ethics Committee Central
Ethics committee address [1] 288188 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6021
Ethics committee country [1] 288188 0
Date submitted for ethics approval [1] 288188 0
13/11/2012
Approval date [1] 288188 0
18/01/2013
Ethics approval number [1] 288188 0
12/CEN/65

Summary
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.
Trial website
none
Trial related presentations / publications
Haeusler S, Parry-Strong A, Krebs JD. The prevalence of low vitamin B12 status in people with type 2 diabetes receiving metformin therapy in New Zealand—a clinical audit. 2014; 127 (1404) ISSN 1175-8716
Public notes

Contacts
Principal investigator
Name 34822 0
Dr Jeremy Krebs
Address 34822 0
Capital and Coast Health Diabetes Research Private Bag 7902 Wellington 6021
Country 34822 0
New Zealand
Phone 34822 0
+6448062458
Fax 34822 0
Email 34822 0
[email protected]
Contact person for public queries
Name 18069 0
Dr Amber Parry Strong
Address 18069 0
Capital and Coast Health
Diabetes Research
Private Bag 7902
Wellington 6021
Country 18069 0
New Zealand
Phone 18069 0
+6448062458
Fax 18069 0
Email 18069 0
[email protected]
Contact person for scientific queries
Name 8997 0
Dr Amber Parry Strong
Address 8997 0
Capital and Coast Health
Diabetes Research
Private Bag 7902
Wellington 6021
Country 8997 0
New Zealand
Phone 8997 0
+6448062458
Fax 8997 0
Email 8997 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSublingual vitamin B12 compared to intramuscular injection in patients with type 2 diabetes treated with metformin: A randomised trial.2016
N.B. These documents automatically identified may not have been verified by the study sponsor.