Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000043235
Ethics application status
Approved
Date submitted
24/06/2008
Date registered
20/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can Calcium and Vitamin D reduce diabetes risk in people at high risk?
Scientific title
Impact of vitamin D and calcium supplementation on the metabolic profile of glucose intolerant and vitamin D deficient obese subjects: a double blind, randomised and controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes (impaired fasting glucose or impaired glucose tolerance) 3305 0
Obesity 3306 0
Vitamin D deficiency 3307 0
Condition category
Condition code
Metabolic and Endocrine 3469 3469 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment group will receive both calcium carbonate tablets 1200 mg daily and cholecalciferol tablets 2,000 IU daily for 6 months. Cholecalciferol will be increased to 4,000 IU daily after 2 months if the serum 25-hydroxyvitamin D levels are less than 75 nmol/L.
Intervention code [1] 3046 0
Treatment: Drugs
Intervention code [2] 3047 0
Prevention
Comparator / control treatment
The control group will receive 2 pills of calcium placebo (sugar pills) and 2 pills of vitamin D placebo tablets (sugar pills) for the first 2 months. The number of vitamin D placebo tablets will increase to 4 pills per day for the rest of the study (4 months) whereas the patients will continue to take 2 pills per day of calcium placebo tablets.
Control group
Placebo

Outcomes
Primary outcome [1] 4372 0
Determine if calcium and vitamin D reduces insulin resistance assessed by homeostasis model assessment of insulin resistance(HOMA-IR)
Timepoint [1] 4372 0
Baseline and 6 months
Primary outcome [2] 4373 0
Determine if calcium and vitamin D improve glucose-stimulated insulin secretion(insulinogenic index and deconvolution analysis of C-peptide after a glucose load)
Timepoint [2] 4373 0
Baseline and 6 months
Primary outcome [3] 4374 0
Determine if calcium and vitamin D improve beta-cell function (disposition index)
Timepoint [3] 4374 0
Baseline and 6 months
Secondary outcome [1] 7377 0
Determine if vitamin D reduces biochemical markers of inflammation associated with increased cardiovascular risk (serum high-sensitive C-reactive protein, fibrinogen, Interleukin-6, Tumor necrosis factor alpha)
Timepoint [1] 7377 0
Baseline and 6 months
Secondary outcome [2] 7378 0
Determine if vitamin D reduces gamma-carboxylation of osteocalcin and increases adiponectin by comparing serum adiponectin levels and the decarboxylated form of osteocalcin before and after treatment
Timepoint [2] 7378 0
Baseline and 6 months
Secondary outcome [3] 7379 0
Determine if calcium and vitamin D improve blood pressure.
Timepoint [3] 7379 0
Blood pressure: 0, 2 and 6 months
Secondary outcome [4] 7380 0
Determine whether vitamin D requirements are influenced by fat mass assessed by dual X-Ray absorptiometry (DXA)
Timepoint [4] 7380 0
Baseline
Secondary outcome [5] 8933 0
Determine if calcium and vitamin D improve the lipid profile (serum total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides).
Timepoint [5] 8933 0
Baseline and 6 months

Eligibility
Key inclusion criteria
Vitamin D deficiency; overweight or obese as defined by a body-mass index (BMI) between 25-35 kg/m2; impaired fasting glucose or impaired glucose tolerance confirmed with a 75g 2h oral glucose tolerance test (OGTT).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy; Breast-feeding; Renal insufficiency; Cirrhosis; Malabsorption; Hypercalcemia; Hypercalciuria; History of nephrolithiasis; Previous non-traumatic fractures; Active or chronic inflammatory disease;Medications known to affect vitamin D, calcium or bone metabolism over the last 3 months; Pharmacological treatment for obesity or medications known to alter glucose metabolism over the last 3 months; Bariatric surgery planned in the next six months or patients who had undergone bariatric surgery in the past; Commenced regular physical activity (more than 3 times/week) in the last 3 months; More than a 5% change in weight in the last 3 months.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be performed by a person external to the study. Allocation will involve contacting the holder of the allocation schedule who will be “off-site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomly assigned to one of two groups, with stratification according to sex, age (< or >50 years of age) and BMI (< or >30 kg/m2). We will use simple randomisation by using a randomisation table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 908 0
3000
Recruitment postcode(s) [2] 909 0
3001
Recruitment postcode(s) [3] 910 0
3002
Recruitment postcode(s) [4] 911 0
3003
Recruitment postcode(s) [5] 912 0
3010
Recruitment postcode(s) [6] 907 0
3011
Recruitment postcode(s) [7] 913 0
3050
Recruitment postcode(s) [8] 914 0
3051
Recruitment postcode(s) [9] 915 0
3052
Recruitment postcode(s) [10] 916 0
3205
Recruitment postcode(s) [11] 917 0
3207
Recruitment postcode(s) [12] 918 0
8001

Funding & Sponsors
Funding source category [1] 3515 0
University
Name [1] 3515 0
Faculty of Medicine, the University of Melbourne (FRC Research Grant)
Country [1] 3515 0
Australia
Funding source category [2] 4349 0
Charities/Societies/Foundations
Name [2] 4349 0
Diabetes Australia (DART grant)
Country [2] 4349 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Ebeling
Address
Department of Medicine (RMH/WH)
Cnr Eleanor and Marion Streets
Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 3155 0
Individual
Name [1] 3155 0
Dr Claudia Gagnon
Address [1] 3155 0
Department of Medicine (RMH/WH)
Cnr Eleanor and Marion Streets
Footscray VIC 3011
Country [1] 3155 0
Australia
Other collaborator category [1] 315 0
Individual
Name [1] 315 0
Dr Zhong X Lu
Address [1] 315 0
103 Victoria Pde
Collingwood VIC 3066
Country [1] 315 0
Australia
Other collaborator category [2] 316 0
Individual
Name [2] 316 0
A/Professor Robin Daly
Address [2] 316 0
Department of Medicine (RMH/WH)
Cnr Eleanor and Marion Streets
Footscray VIC 3011
Country [2] 316 0
Australia
Other collaborator category [3] 317 0
Individual
Name [3] 317 0
A/Professor Andre Carpentier
Address [3] 317 0
3001, 12th Ave North
Fleurimont, Quebec, Canada
J1H 5N4
Country [3] 317 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5550 0
Human Research Ethics Committee of Melbourne Health
Ethics committee address [1] 5550 0
Research Directorate
PO Royal Melbourne Hospital
Parkville VIC 3050
Ethics committee country [1] 5550 0
Australia
Date submitted for ethics approval [1] 5550 0
21/11/2007
Approval date [1] 5550 0
21/05/2008
Ethics approval number [1] 5550 0
2007.270

Summary
Brief summary
Type 2 diabetes is Australia's fastest growing chronic disease. Simple strategies to prevent this disease at an early stage (pre-diabetes) in people at high risk are urgently needed. Recently, a lack of calcium and vitamin D has been associated with the development of diabetes. This 6-month study will determine if taking vitamin D and calcium supplements could decrease diabetes risk and cardiovascular risk factors in overweight or obese people with pre-diabetes who lack vitamin D. It will also increase our understanding of the mechanisms through which vitamin D and calcium alter diabetes and cardiovascular disease risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28698 0
Address 28698 0
Country 28698 0
Phone 28698 0
Fax 28698 0
Email 28698 0
Contact person for public queries
Name 11855 0
Dr Claudia Gagnon
Address 11855 0
Department of Medicine (RMH/WH)
Cnr Eleanor and Marion Streets
Footscray VIC 3011
Country 11855 0
Australia
Phone 11855 0
+61 3 8345 7117
Fax 11855 0
+61 3 9318 1157
Email 11855 0
cgagnon@unimelb.edu.au
Contact person for scientific queries
Name 2783 0
Professor Peter Ebeling
Address 2783 0
Department of Medicine (RMH/WH)
Cnr Eleanor and Marion Streets
Footscray VIC 3011
Country 2783 0
Australia
Phone 2783 0
+61 3 8345 6429
Fax 2783 0
+61 3 9318 1157
Email 2783 0
peterre@unimelb.edu.au

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

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