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Trial registered on ANZCTR


Registration number
ACTRN12611000950965
Ethics application status
Approved
Date submitted
29/08/2011
Date registered
5/09/2011
Date last updated
5/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of outcomes from correction of vitamin D levels in residential care facility residents
Scientific title
A randomised, double-blind, placebo controlled cohort study of the benefits of sufficient levels of vitamin D3 as defined by decreasing the number of fractures, acute illnesses and exacerbation of chronic conditions, the need for hospitalisation as well as the mortality rate for permanent residents of residential care facilities.
Secondary ID [1] 262817 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractures 270536 0
acute illnesses and exacerbation of chronic conditions 270537 0
the need of hospitalisation 270538 0
the mortality rate 270539 0
Vitamin D deficiency 270688 0
Condition category
Condition code
Public Health 270697 270697 0 0
Other public health
Metabolic and Endocrine 270861 270861 0 0
Metabolic disorders
Injuries and Accidents 270862 270862 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin D3 - Cholecalciferol 1000IU. Unscored white tablet with D3 on one side.
Loading dose of 3000IU daily for six weeks, then 1000IU daily taken daily for 12 months. Total trial period is 58 weeks.
Intervention code [1] 269166 0
Treatment: Drugs
Intervention code [2] 269309 0
Prevention
Comparator / control treatment
Two separate control groups will be used:
1. The placebo group recieve an enteric coated unscored white tablet (placebo) with identical appearance to the vitamin D tablet of the study group. It is taken initially at 3000IU per day for six weeks then 1000IU daily for 52weeks (total trial period of 58 weeks).

2. The "no treatment group" will be allocated from those consenting participants who have serum 25(OH)D levels > 50nmol/L. These participants will be permenant residential aged care residents who are under current GP management and may or may not be on Vitamin D medication. This group represent the current, standard residential population without study input.
Control group
Placebo

Outcomes
Primary outcome [1] 269411 0
Changes in the frequency of unplanned hospital and GP visits.
The research nurse will regularly conduct a data search from participants' medical records at Aged Care Facilities, and ACT Health hospital databases to obtain such information.
Timepoint [1] 269411 0
14 months following randomisation.
Primary outcome [2] 269412 0
Changes in the frequency of fractures
The research nurse will regularly a conduct data search from participants medical records at the Residential Aged Care Facilities, and ACT Health hospital databases to obtain such information.
Timepoint [2] 269412 0
14 months following randomisation.
Primary outcome [3] 269413 0
Changes in mortality rate.
The research nurse will regularly conduct a data search from participants medical records at Residential Aged Care Facilities, and ACT Health hospitals to obtain such information. At the end of the study, formal requests will be made to Australia's National Agency for Health and Welfare Statistics and Information (AIHW) to validate with in-house data collection.
Timepoint [3] 269413 0
14 months following randomisation.
Secondary outcome [1] 287774 0
The prevalence of vitamin D deficiency in the studied cohort. At the initial visit, the research nurse will collect baseline blood samples from partcipants to detemine their background vitamin D levels.
Timepoint [1] 287774 0
14 months following randomisation.

Eligibility
Key inclusion criteria
Permenant residents of long-term care facilities in the ACT.
Aged 65 years or more.
Willing to partipate in the study.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents with Aged Care Assesment Team ACFI assessment of 'High' for behaviour (verbal or physical).

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)
Residential Aged Care Facilities will be invited to participate in the study and with their consent for their residents to be approached. The RACF mail-out database will be accessed and letters sent to all potenial participants guardians. Interested potential participants will return the study consent forms, after which they will be approached by the study team and initial bloods taken. On review of the pathology results randomisation to one of the two treatment arms will occur and participants commenced on treatment or placebo. At six weeks participants will be retested for 25(OH)D levels and maintenance treatment commenced. Baseline measures and outcome data will be collected from participants quarterly. The final pathology test will be collected from each participant at the end of the study.
A research associate will create a computer generated list of random numbers to allocate to the study participants. The study participant is allocated to the study arm based on the initial pathology results by the research associate who is based at the central administration site. The research associate packs the allocated study drug into sealed non-transparent packages with the allocated study drug number on it, and these are delivered by another member of the research team to the participating pharmacies.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list (placebo and study) will be generated using a random allocation generator tool. These will be attached in the order they present in the list, to each newly consented participant with a 25(OH) vitamin D level < 50nmol/L. Of the 250 recruits, those participants with serum 25(OH) vitamin D levels of 50nmol/L or greater will be categorised as group 3 and not receive any intervention. 12-month prospective clinical data will be recorded and examined for comparison analysis with randomised participants in groups 1 and 2.

All researchers (apart from the associate researcher doing the randomisation), remain blinded to treatment allocation throughout the study.

There will be no randomisation process attached to the selection of group 3 participants with serum 25(OH) vitamin D levels =/> 50nmol/L.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4342 0
2605
Recruitment postcode(s) [2] 4343 0
2611
Recruitment postcode(s) [3] 4344 0
2603
Recruitment postcode(s) [4] 4345 0
2614
Recruitment postcode(s) [5] 4346 0
2617
Recruitment postcode(s) [6] 4347 0
2615
Recruitment postcode(s) [7] 4348 0
2602
Recruitment postcode(s) [8] 4349 0
2607
Recruitment postcode(s) [9] 4350 0
2904
Recruitment postcode(s) [10] 4351 0
2604
Recruitment postcode(s) [11] 4352 0
2602

Funding & Sponsors
Funding source category [1] 269643 0
Government body
Name [1] 269643 0
Private Practice Fund Administration
Country [1] 269643 0
Australia
Primary sponsor type
Government body
Name
ACT Government Health Directorate
Address
Canberra Hospital
Yamba Drive,
Garran, ACT 2605
Country
Australia
Secondary sponsor category [1] 268774 0
None
Name [1] 268774 0
Address [1] 268774 0
Country [1] 268774 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269588 0
ACT Government Health Directorate Human Research Ethics Committee
Ethics committee address [1] 269588 0
Ethics committee country [1] 269588 0
Australia
Date submitted for ethics approval [1] 269588 0
10/03/2011
Approval date [1] 269588 0
10/08/2011
Ethics approval number [1] 269588 0
ETH.3.11.036

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33003 0
Address 33003 0
Country 33003 0
Phone 33003 0
Fax 33003 0
Email 33003 0
Contact person for public queries
Name 16250 0
Dr. W. Srikusalanukul
Address 16250 0
Clinical Trials Unit
Canberra Hospital
Yamba Drive,
Garran, ACT 2605
Country 16250 0
Australia
Phone 16250 0
+61 2 6244 4251
Fax 16250 0
+61 2 6244 4036
Email 16250 0
[email protected]
Contact person for scientific queries
Name 7178 0
A/Prof. Michael Davis
Address 7178 0
Department of Geriatric Medicine
Canberra Hospital
Building 3, Level 2.
Yamba Drive,
Garran, ACT 2605
Country 7178 0
Australia
Phone 7178 0
+61 2 6244 4192
Fax 7178 0
+61 2 6244 4036
Email 7178 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
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Documents added automatically
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