CompletedPhase 3ACTRN12611000402943
Effect of Vitamin D Supplementation on Cardiovascular and Respiratory Disease Event Rates, and the incidence of fractures
Effect of Vitamin D Supplementation on Cardiovascular and Respiratory Disease Event Rates in Older Adults, and the incidence of non-vertebral fractures.
Sponsor
University of Auckland
Enrollment
5,110 participants
Start Date
Jun 3, 2011
Study Type
Interventional
Conditions
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.
Eligibility
Sex: Both males and femalesMin Age: 50 YearssMax Age: 84 Yearss
Inclusion Criteria4
- age 50-84 years;
- ability to give informed consent;
- resident in Auckland at recruitment;
- anticipated residence in New Zealand for the 4-year study period.
Exclusion Criteria5
- current use of vitamin D supplements (>600 IU per day if aged 50-70 years; >800 IU per day if aged 71-84 years);
- 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
- history of hypercalcaemia, nephrolithiasis, sarcoidosis, parathyroid disease or gastric bypass surgery;
- enrolled in another study which could affect participation in the vitamin D study;
- serum calcium from baseline blood sample >2.50 mmol/L.
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Interventions
Vitamin D3 (cholecalciferol) 200,000 IU oral capsule at baseline, then 100,000 IU oral capsule monthly for 4 years
Vitamin D3 (cholecalciferol) 200,000 IU oral capsule at baseline, then 100,000 IU oral capsule monthly for 4 years
Locations(1)
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ACTRN12611000402943
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