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Trial registered on ANZCTR


Registration number
ACTRN12611001023943
Ethics application status
Approved
Date submitted
23/09/2011
Date registered
26/09/2011
Date last updated
26/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial of high dose oral vitamin D in type 2 diabetes
Scientific title
A randomised control trial of high dose cholecalciferol in type 2 diabetes to assess C-peptide secretion.
Secondary ID [1] 263098 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 270851 0
Metabolic function 270852 0
Condition category
Condition code
Metabolic and Endocrine 271028 271028 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Cholecalciferol: 10,000 IU/ day for 2 weeks then 6000 IU/ day for 22 weeks
Intervention code [1] 269445 0
Treatment: Drugs
Comparator / control treatment
Placebo: Tablets were identical in appearance to vitamin D but without vitamin D.
Control group
Placebo

Outcomes
Primary outcome [1] 279687 0
Glucagon-stimulated change in C-peptide [delta C-peptide (DCP)]. 1mg of glucagon was injected intravenously. Serum C-peptide was measured pre and 6 minutes post the glucagon injection.
Timepoint [1] 279687 0
baseline, 3 months, 6 months
Secondary outcome [1] 294220 0
HOMA-IR, a measure of insulin resistance was calculated from participant's serum insulin and glucose by the formula :plasma insulin x plasma glucose / 22.5.
Timepoint [1] 294220 0
baseline, 3 months, 6 months
Secondary outcome [2] 294221 0
HbA1c, a measure of glycemic control over the last 2-3 months was measured in the serum.
Timepoint [2] 294221 0
baseline, 3 months, 6 months
Secondary outcome [3] 294222 0
Fasting plasma glucose was measured in participants plasma.
Timepoint [3] 294222 0
baseline, 3 months, 6 months
Secondary outcome [4] 294223 0
Post-prandial capillary blood glucose was measured by capillary glucose readings on a home glucometer, measured by participants 2 hours after meals for 48 hours prior to each visit.
Timepoint [4] 294223 0
baseline, 3 months, 6 months

Eligibility
Key inclusion criteria
diabetes diagnosed in the preceding 12 months, age 30- 60, not on insulin treatment, serum vitamin 25-D3 28-85nmol/L glycated hemoglobin (HbA1c) < 8%.
Minimum age
30 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
insulin treatment, liver impairment, renal impairment (eGFR <50ml/min), hyperparathyroidism, family or personal history of renal calculi, history of recurrent falls, use of a gait aid, past history of a fragility fracture, personal or family history of osteoporosis and current treatment with oral prednisolone, methotrexate or other immunosuppressive drugs.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 269926 0
Charities/Societies/Foundations
Name [1] 269926 0
Diabetes Australia Research Trust
Address [1] 269926 0
GPO BOX 3156
CANBERRA ACT 2601
Country [1] 269926 0
Australia
Funding source category [2] 269927 0
Charities/Societies/Foundations
Name [2] 269927 0
Munro Foundation
Address [2] 269927 0
c/o 1G Royal Parade Parkville, VIC, 3050
Country [2] 269927 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Royal Parade, Parkville, VIC 3050
Country
Australia
Secondary sponsor category [1] 268928 0
None
Name [1] 268928 0
Address [1] 268928 0
Country [1] 268928 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim was to investigate the effect of high dose oral cholecalciferol (vitamin D3) on pancreatic beta-cell function and glycemia in adults with type 2 diabetes. The hypothesis was that vitamin D would improve beta-cell function and glycemia.

Beta-cell function was assessed by measuring glucagon stimulated C-peptide. Insulin resistance was measured by calculating a HOMA-IR index from plasma insulin and glucose levels. Glycemia was assessed by measuring fasting plasma glucose, post-prandial capillary glucose and serum glycosylated haemaglobin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33195 0
Address 33195 0
Country 33195 0
Phone 33195 0
Fax 33195 0
Email 33195 0
Contact person for public queries
Name 16442 0
Shirley Elkassaby
Address 16442 0
Royal Melbourne Hospital
Department of Endocrinology
Royal Parade, Parkville,
VIC, 3050
Country 16442 0
Australia
Phone 16442 0
+61 3 9342-7365
Fax 16442 0
Email 16442 0
selkassaby@hotmail.com
Contact person for scientific queries
Name 7370 0
Shirley Elkassaby
Address 7370 0
Royal Melbourne Hospital
Department of Endocrinology
Royal Parade, Parkville, VIC 3050
Country 7370 0
Australia
Phone 7370 0
+61 3 9342-7365
Fax 7370 0
Email 7370 0
selkassaby@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary