Trial from ANZCTR


Trial ID ACTRN12611000402943
Trial Status: Registered
Date Submitted: 8/04/2011
Date Registered: 18/04/2011
Retrospectively registered

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Public title Effect of Vitamin D Supplementation on Cardiovascular and Respiratory Disease Event Rates, and the incidence of fractures
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Effect of Vitamin D Supplementation on Cardiovascular and Respiratory Disease Event Rates in Older Adults, and the incidence of non-vertebral fractures.
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Secondary ID [1] 259952 0
HRC 10/400
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UTN U1111-1120-6224
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Trial acronym ViDA (Vitamin D Assessment) Trial
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Health condition(s) or problem(s) studied:
Cardiovascular Disease 265577 0
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Respiratory Disease 265578 0
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Non-vertebral fractures 265579 0
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Condition category: Condition code:
Cardiovascular Coronary heart disease
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265722 265722 0 0
Respiratory Chronic obstructive pulmonary disease
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265723 265723 0 0
Injuries and Accidents Fractures
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265724 265724 0 0

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Descriptions of intervention(s) / exposure Vitamin D3 (cholecalciferol) 200,000 IU oral capsule at baseline, then 100,000 IU oral capsule monthly (aside from 200,000 IU oral capsule in each June) for 4 years
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Intervention Code:
Prevention 264364 0
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Comparator / control treatment Placebo capsule with sunflower lecithin
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Control group Placebo
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Primary Outcome: Incidence rate of fatal and non-fatal cardiovascular disease, as assessed by mortality, hospital discharges and family doctors. 266486 0
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Timepoint: 4 years and 6 months after randomisation of first participant. 266486 0
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Secondary Outcome: Incidence rate of respiratory disease, as assessed by mortality, hospital discharges and consultations with family doctors. 273883 0
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Timepoint: 4 years and 6 months after randomisation of first participant. 273883 0
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Secondary Outcome: Incidence rate of non-vertebral fractures, as assessed by hospital discharges, consultations with family doctors and self-reported questionnaires. 273884 0
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Timepoint: 4 years and 6 months after randomisation of first participant. 273884 0
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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.
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Minimum age 50 Years
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Maximum age 84 Years
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Gender Both males and females
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Healthy volunteers? Yes
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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.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3
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Anticipated date of first participant enrolment 7/04/2011
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 5100
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

Country: New Zealand 3345 0
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State/Province: Auckland 3345 0
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Funding Source: Government body 264839 0
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Name: Health Research Council of New Zealand 264839 0
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Address: Level 3 - ProCare Building,
110 Stanley Street,
Auckland, 1010.
264839 0
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Country: New Zealand 264839 0
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Funding Source: Government body 264840 0
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Name: Accident Compensation Commission 264840 0
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Address: 80-83 Molesworth St.,
Wellington, 6140
264840 0
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Country: New Zealand 264840 0
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Primary Sponsor University
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Name: University of Auckland
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Address: School of Population Health,
Tamaki Campus,
University of Auckland,
Private Bag 92019,
Auckland, 1142
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Country: New Zealand
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Secondary Sponsor: Individual 263942 0
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Name: Carlos A. Camargo, Jr, MD DrPH (Co-PI) 263942 0
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Address: Massachusetts General Hospital
326 Cambridge St, Suite 410
Boston
Massachusetts 02114
263942 0
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Country: United States of America 263942 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Multi Region Ethics Committee 266805 0
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Address: c/- Ministry of Health
1-3 The Terrace
Level 1
Wellington 6011
266805 0
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Country: New Zealand 266805 0
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Approval Date: 21/10/2010 266805 0
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Submitted Date: 266805 0
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HREC: MEC/09/08/082 266805 0
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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.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Robert Scragg
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Address: School of Population Health, University of Auckland, Tamaki Campus, Private Bag 92019, Auckland Mail Centre 1142.
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Country: New Zealand
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Tel: +64-9-3737 599, ext 86336
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Email: r.scragg@auckland.ac.nz
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Contact person for scientific queries
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Name: Robert Scragg
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Address: School of Population Health, University of Auckland, Tamaki Campus, Private Bag 92019, Auckland Mail Centre 1142.
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Country: New Zealand
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Tel: +64-9-3737 599, ext 86336
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Email: r.scragg@auckland.ac.nz
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Contact person responsible for updating information
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Name: Robert Scragg
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Address: School of Population Health, University of Auckland, Tamaki Campus, Private Bag 92019, Auckland Mail Centre 1142.
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Country: New Zealand
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Addition Cancer fields
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