ActivePhase 3ACTRN12613000743763

The D-Health Trial: A trial of vitamin D for prevention of mortality and cancer in older Australian adults.

A randomised placebo-controlled trial of high-dose vitamin D supplementation for prevention of mortality and cancer in Australian adults aged 60-79.

Sponsor

QIMR Berghofer Medical Research Institute

Enrollment

25,000 participants

Start Date

Jan 7, 2014

Study Type

Interventional

Conditions

Cancer Mortality

Summary

Vitamin D in your body comes from exposure to the sun or from your diet. Having enough vitamin D in your blood stream is important for maintaining healthy bones, but we don’t really know how much our bones need. Having higher vitamin D levels might also reduce risks of diseases such as diabetes, heart disease, multiple sclerosis and some cancers, but this is uncertain. To fully understand the health effects of vitamin D we need to do studies with very large numbers of people. We are aiming to recruit about 25,000 Australians aged 60-79. The aims are to see if taking a vitamin D tablet changes the risk of a person being diagnosed with health conditions such as cancer, heart disease or infections (like flu). D-Health will give us much-needed information so that we can advise people correctly in the future.

Eligibility

Sex: Both males and femalesMin Age: 60 YearssMax Age: 79 Yearss

Inclusion Criteria4

Aged 60 to 79 years old
Enrolled to vote
Do not have any of the health conditions listed in exclusions criteria and are not cognitively impaired
Are not taking vitamin D at doses greater than 500 IU/day

Exclusion Criteria5

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 form that they:
Have any of the following medical conditions (which either preclude or require high dose vitamin D supplementation or prevent informed consent): hyperparathyroidism, sarcoidosis, osteomalacia, osteoporosis, a history of renal calculi, a history of high calcium
Are taking vitamin D at doses greater than 500 IU/day
Cognitive impairment
Do not have a telephone (landline or mobile)

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Interventions

Intervention Arm: An oral tablet containing 60,000IU of Vitamin D taken once a month for 5 years. Participant adherence to the intervention will be monitored through annual surveys where participant

Intervention Arm: An oral tablet containing 60,000IU of Vitamin D taken once a month for 5 years. Participant adherence to the intervention will be monitored through annual surveys where participants will be asked the number of tablets taken and whether they have started taking off-label vitamin D supplements. A random sample of participants from each arm of the study will be asked to supply a blood sample for testing of 25 hydroxy vitamin D (25(OH)D).