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Trial registered on ANZCTR


Trial ID
ACTRN12611000402943
Ethics application status
Approved
Date submitted
8/04/2011
Date registered
18/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Vitamin D Supplementation on Cardiovascular and Respiratory Disease Event Rates, and the incidence of fractures
Scientific title
Effect of Vitamin D Supplementation on Cardiovascular and Respiratory Disease Event Rates in Older Adults, and the incidence of non-vertebral fractures.
Secondary ID [1] 259952 0
HRC 10/400
Universal Trial Number (UTN)
U1111-1120-6224
Trial acronym
ViDA (Vitamin D Assessment) Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 265577 0
Respiratory Disease 265578 0
Non-vertebral fractures 265579 0
Condition category
Condition code
Cardiovascular 265722 265722 0 0
Coronary heart disease
Respiratory 265723 265723 0 0
Chronic obstructive pulmonary disease
Injuries and Accidents 265724 265724 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin D3 (cholecalciferol) 200,000 IU oral capsule at baseline, then 100,000 IU oral capsule monthly for 4 years
Intervention code [1] 264364 0
Prevention
Comparator / control treatment
Placebo capsule with sunflower lecithin
Control group
Placebo

Outcomes
Primary outcome [1] 266486 0
Incidence rate of fatal and non-fatal cardiovascular disease, as assessed by mortality, hospital discharges and family doctors.
Timepoint [1] 266486 0
4 years and 6 months after randomisation of first participant.
Secondary outcome [1] 273883 0
Incidence rate of respiratory disease, as assessed by mortality, hospital discharges and consultations with family doctors.
Timepoint [1] 273883 0
4 years and 6 months after randomisation of first participant.
Secondary outcome [2] 273884 0
Incidence rate of non-vertebral fractures, as assessed by hospital discharges, consultations with family doctors and self-reported questionnaires.
Timepoint [2] 273884 0
4 years and 6 months after randomisation of first participant.

Eligibility
Key inclusion criteria
1. age 50-84 years;
2. ability to give informed consent;
3. resident in Auckland at recruitment;
4. anticipated residence in New Zealand for the 4-year study period.
Minimum age
50 Years
Maximum age
84 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. current use of vitamin D supplements (>600 IU per day if aged 50-70 years; >800 IU per day if aged 71-84 years);
2. diagnosis of psychiatric disorders that would limit ability to comply with study protocol - ie. history of regular exacerbation of major psychosis (schizophrenia, bipolar disorder) in last 2 years
3. history of hypercalcaemia, nephrolithiasis, sarcoidosis, parathyroid disease or gastric bypass surgery;
4. enrolled in another study which could affect participation in the vitamin D study;
5. serum calcium from baseline blood sample >2.50 mmol/L.

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)
Participants will be recruited from patient registers of general practitioners in Auckland.

Once eligibility is confirmed, randomisation to either arm of the study will be done by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation with variable block size within 5 year age and ethnic strata.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy

Recruitment
Recruitment status
Active, not recruiting
Anticipated date of first participant enrolment
7/04/2011
Actual date of first participant enrolment
3/06/2011
Anticipated date last participant enrolled
Actual date last participant enrolled
23/01/2013
Anticipated date of last data collection
Actual date of last data collection
Target sample size
5110
Actual sample size
Recruitment outside Australia
Country [1] 3345 0
New Zealand
State/province [1] 3345 0
Auckland

Funding & Sponsors
Funding source category [1] 264839 0
Government body
Name [1] 264839 0
Health Research Council of New Zealand
Address [1] 264839 0
Level 3 - ProCare Building,
110 Stanley Street,
Auckland, 1010.
Country [1] 264839 0
New Zealand
Funding source category [2] 264840 0
Government body
Name [2] 264840 0
Accident Compensation Commission
Address [2] 264840 0
80-83 Molesworth St.,
Wellington, 6140
Country [2] 264840 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Population Health,
Tamaki Campus,
University of Auckland,
Private Bag 92019,
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 263942 0
Individual
Name [1] 263942 0
Carlos A. Camargo, Jr, MD DrPH (Co-PI)
Address [1] 263942 0
Massachusetts General Hospital
326 Cambridge St, Suite 410
Boston
Massachusetts 02114
Country [1] 263942 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266805 0
Multi Region Ethics Committee
Ethics committee address [1] 266805 0
c/- Ministry of Health
1-3 The Terrace
Level 1
Wellington 6011
Ethics committee country [1] 266805 0
New Zealand
Date submitted for ethics approval [1] 266805 0
Approval date [1] 266805 0
21/10/2010
Ethics approval number [1] 266805 0
MEC/09/08/082

Summary
Brief summary
The main aims of the study are to see if vitamin D supplementation reduces the incidence rates of cardiovascular disease, respiratory disease and non-vertebral fractures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32455 0
Prof Robert Scragg
Address 32455 0
School of Population Health,
University of Auckland, Tamaki Campus,
Private Bag 92019, Auckland Mail Centre 1142,
Auckland, New Zealand
Country 32455 0
New Zealand
Phone 32455 0
+64-9-9236336
Fax 32455 0
Email 32455 0
r.scragg@auckland.ac.nz
Contact person for public queries
Name 15702 0
Prof Robert Scragg
Address 15702 0
School of Population Health,
University of Auckland, Tamaki Campus,
Private Bag 92019, Auckland Mail Centre 1142,
Auckland, New Zealand
Country 15702 0
New Zealand
Phone 15702 0
+64-9-3737 599, ext 86336
Fax 15702 0
Email 15702 0
r.scragg@auckland.ac.nz
Contact person for scientific queries
Name 6630 0
Prof Robert Scragg
Address 6630 0
School of Population Health,
University of Auckland, Tamaki Campus,
Private Bag 92019, Auckland Mail Centre 1142,
Auckland, New Zealand.
Country 6630 0
New Zealand
Phone 6630 0
+64-9-3737 599, ext 86336
Fax 6630 0
Email 6630 0
r.scragg@auckland.ac.nz