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Trial registered on ANZCTR


Registration number
ACTRN12609001063202
Ethics application status
Approved
Date submitted
9/12/2009
Date registered
10/12/2009
Date last updated
9/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial of vitamin D for the reduction of chronic disease and mortality in older adults.
Scientific title
A randomised placebo-controlled double-blind trial with participants randomised to receive either placebo, 60,000 International Units per month (IU/month) of vitamin D3 or 30,000 IU/month of vitamin D3, each taken once a month for 12 months with an aim to determine the feasibility and inform the design of a large-scale randomised, placebo-controlled chemoprevention trial of vitamin D3 (cholecalciferol) for the reduction of total mortality.
Secondary ID [1] 1181 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This trial is using healthy volunteers from the electoral roll. The overall aim of this study is to determine the feasibility and inform the design of a large-scale randomised, placebo-controlled chemoprevention trial of vitamin D3 (cholecalciferol) for the reduction of total mortality. 252375 0
Condition category
Condition code
Public Health 252513 252513 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: 30,000 IU/month of vitamin D3 (cholecalciferol) for 12 months.

Intervention 2: 60,000 IU/month of vitamin D3 for 12 months.

The vitamin D3 and placebo will be supplied as identical capsules.
Intervention code [1] 255637 0
Prevention
Comparator / control treatment
Intervention 3: Patients randomised to the placebo arm will receive one placebo capsule per month for 12 months.
Control group
Placebo

Outcomes
Primary outcome [1] 253440 0
Feasibility: recruitment rate and representativeness
Timepoint [1] 253440 0
Using baseline questionnaires to assess variation in participation across population subgroups.
Primary outcome [2] 253441 0
Feasibility: compliance (self report)
Timepoint [2] 253441 0
At the end of the intervention participants will be asked to report the number of tablets taken.
Primary outcome [3] 253442 0
Feasibility: compliance (serum Vitamin D levels)
Timepoint [3] 253442 0
Blood tests will be taken at baseline and at 12 months (cessation of the intervention).
Secondary outcome [1] 262570 0
Nil
Timepoint [1] 262570 0
Nil

Eligibility
Key inclusion criteria
Residents in Queensland, New South Wales, Tasmania and Victoria aged between 60 and 85 years will be selected at random from the Commonwealth Electoral Roll. Half will be selected from capital cities and half from regional centres, selecting from postcodes that are within 20 kilometres of a pathology collection clinic. Selection will be stratified by state, region, age (in five-year age bands) and sex to ensure an equal state, region, age- and sex-distribution.
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People will be excluded if they are unable to give consent or to communicate well enough in English to understand study materials or if they indicate in an initial screening questionnaire that they:

1.Have any of the following medical conditions (which either preclude or require high dose vitamin D supplementation or prevent informed consent): hyperparathyroidism, sarcoidosis, nephrolithiasis, osteomalacia, osteoporosis, a history of renal calculi or colic

2. Are taking vitamin D at doses >600IU/day
3. Do not have a telephone (landline or mobile)

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)
660 participants will be targeted for randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation - participants will be stratified according to state, metropolitan/regional residence and sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2010
Actual
10/09/2010
Date of last participant enrolment
Anticipated
Actual
1/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
660
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256116 0
Government body
Name [1] 256116 0
National Health and Medical Research Council
Country [1] 256116 0
Australia
Primary sponsor type
Government body
Name
Queensland Institute of Medical Research
Address
QIMR
300 Herston Road
Herston
Brisbane
QLD
4006
Country
Australia
Secondary sponsor category [1] 251496 0
None
Name [1] 251496 0
Address [1] 251496 0
Country [1] 251496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258210 0
Queensland Institute of Medical Research Human Research Ethics Committee
Ethics committee address [1] 258210 0
QIMR HREC
300 Herston Road
Herston
Brisbane
QLD
4006
Ethics committee country [1] 258210 0
Australia
Date submitted for ethics approval [1] 258210 0
01/02/2009
Approval date [1] 258210 0
Ethics approval number [1] 258210 0
P1294:

Summary
Brief summary
Observational studies, mostly from Europe and North America, suggest that people with low vitamin D status may have increased risks of some chronic diseases and death. Given that sunlight is essential for vitamin D synthesis this has prompted calls from some to relax sun protection messages or so increased population-wide vitamin D supplementation through expanded mandatory food fortification. However there is no strong evidence from clinical trials to support these measures and the International Agency for Research on Cancer has specifically called for randomised trials of high dose vitamin D supplementation for prevention of cancer and lowering of total mortality. We propose here to assess the feasibility of such a trial in the four eastern states of Australia. Participants randomly selected from the electoral roll will be invited to participate, and randomly assigned to a monthly intake of one of two vitamin D doses (60,000 IU/month or 30,000 IU/month) or placebo for 12 months. Baseline and post-intervention serum vitamin D levels will be measured. Outcomes will be recruitment rate, representativeness of the general population, change in vitamin D levels according to population subgroup and economics.
Trial website
Trial related presentations / publications
1. Tran B, Armstrong BK, Ebeling PR, English DR, Kimlin MG, van der Pols JC, Venn A, Gebski, V, Whiteman DC, Webb PM, Neale RE. Effect of vitamin D supplementation on antibiotic use: a randomized controlled trial. Am J Clin Nutr 2013 ;79:631-640

2. Tran B, Armstrong BK, McGeechan K, Ebeling PR, English DR, Kimlin MG, Lucas R, van der Pols JC, Venn A, Gebski V, Whiteman DC, Webb PM, Neale RE. Predicting vitamin D deficiency in older Australian adults. Clin Endocrinol. 2013 (Mar 28, Epub ahead of print)

3. Tran B, Armstrong BK, Carlin JB, Ebeling PR, English DR, Kimlin MG, Rahman B, van der Pols JC, Venn A, Gebski V, Whiteman DC, Webb PM and Neale RE. Recruitment and Results of a Pilot Trial of Vitamin D Supplementation in the General Population of Australia. J Clin Endocrinol Metab 2012;97:4473-80
Public notes

Contacts
Principal investigator
Name 30569 0
Dr Rachel Neale
Address 30569 0
Cancer and Population Studies Group QIMR Berghofer
300 Herston Road Herston Brisbane QLD 4006
Country 30569 0
Australia
Phone 30569 0
+61 7 3845 3598
Fax 30569 0
+61 7 3845 3502
Email 30569 0
[email protected]
Contact person for public queries
Name 13816 0
Rachel Neale
Address 13816 0
Cancer and Population Studies Group QIMR Berghofer
300 Herston Road Herston Brisbane QLD 4006
Country 13816 0
Australia
Phone 13816 0
+61 7 3845 3598
Fax 13816 0
+61 7 3845 3502
Email 13816 0
[email protected]
Contact person for scientific queries
Name 4744 0
Rachel Neale
Address 4744 0
Cancer and Population Studies Group QIMR Berghofer
300 Herston Road Herston Brisbane QLD 4006
Country 4744 0
Australia
Phone 4744 0
+61 7 3845 3598
Fax 4744 0
+61 7 3845 3502
Email 4744 0
[email protected]

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