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Trial registered on ANZCTR


Registration number
ACTRN12610000322033
Ethics application status
Approved
Date submitted
19/04/2010
Date registered
21/04/2010
Date last updated
21/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of vitamin D in the treatment of nerve pain in diabetes
Scientific title
Vitamin D as an analgesic for neuropathic pain in type 2 diabetes
Secondary ID [1] 251637 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic pain in type 2 diabetes 257138 0
Condition category
Condition code
Metabolic and Endocrine 257295 257295 0 0
Diabetes
Neurological 257359 257359 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramuscular vitamin D injection (300,000 units) at baseline
Intervention code [1] 256294 0
Treatment: Drugs
Comparator / control treatment
Placebo injection with normal saline at baseline
Control group
Placebo

Outcomes
Primary outcome [1] 258200 0
Pain scores on questionnaires (visual analogue scale, McGill short form pain questionnaire)
Timepoint [1] 258200 0
baseline and at 3 months and 6 months following randomisation
Secondary outcome [1] 263850 0
Quality of life (SF-36)
Timepoint [1] 263850 0
Baseline and 3 months and 6 months following randomisation
Secondary outcome [2] 263851 0
Changes in severity of neuropathy on clinical examination and by biothesiometry.
Timepoint [2] 263851 0
Baseline and 3 months and 6 months after randomisation

Eligibility
Key inclusion criteria
Patients with type 2 diabetes and with painful neuropathy with a serum 25-hydroxyvitamin D level of less than 50 nmol/L
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with type 1 or secondary diabetes, hypercalcaemia or renal stone

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)
Eligible patients are recruited from hospital clinics. Patients are randomized to vitamin D or placebo injection by a computer randomization program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomization program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2820 0
2010

Funding & Sponsors
Funding source category [1] 256797 0
Commercial sector/Industry
Name [1] 256797 0
Novo Nordisk Pharmaceuticals Pty. Ltd
Address [1] 256797 0
Level 3
21 Solent Circuit
BAULKHAM HILLS NSW 2153
Country [1] 256797 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria Street, Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 256072 0
Hospital
Name [1] 256072 0
Concord Repatriation General Hospital
Address [1] 256072 0
Concord Repatriation General Hospital
Hospital Rd, Concord NSW 2139
Country [1] 256072 0
Australia
Secondary sponsor category [2] 256073 0
Other Collaborative groups
Name [2] 256073 0
Garvan Institute of Medical Research
Address [2] 256073 0
384 Victoria Street
Darlinghurst
New South Wales 2010
Country [2] 256073 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258820 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 258820 0
St Vincent's Hospital
390 Victoria Street, Darlinghurst
NSW 2010
Ethics committee country [1] 258820 0
Australia
Date submitted for ethics approval [1] 258820 0
Approval date [1] 258820 0
Ethics approval number [1] 258820 0

Summary
Brief summary
Vitamin D deficiency is common amongst people with type 2 diabetes. People with type 2 diabetes frequently develop painful neuropathy ("nerve pain" especially in the feet). The study hypothesis is that vitamin D supplementation may improve symptoms of nerve pain. The study is therefore designed to investigate the impact of vitamin D supplementation on nerve pain in people with type 2 diabetes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31038 0
Address 31038 0
Country 31038 0
Phone 31038 0
Fax 31038 0
Email 31038 0
Contact person for public queries
Name 14285 0
Paul Lee
Address 14285 0
Department of Endocrinology
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
New South Wales 2010
Country 14285 0
Australia
Phone 14285 0
+61 2 9295 8486
Fax 14285 0
+61 2 9295 8481
Email 14285 0
p.lee@garvan.org.au
Contact person for scientific queries
Name 5213 0
Paul Lee
Address 5213 0
Department of Endocrinology
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
New South Wales 2010
Country 5213 0
Australia
Phone 5213 0
+61 2 9295 8486
Fax 5213 0
+61 2 9295 8481
Email 5213 0
p.lee@garvan.org.au

No information has been provided regarding IPD availability
Summary results
No Results