Who is conducting the study?
Why study vitamin D?
Who can take part?
What will I be asked to do?
What are the benefits of taking part in the study?
What are the possible risks of taking part?
How will D-Health find out details about participants' health?
What about confidentiality?
Can participants take their own vitamin D tablets?
Future research using my information
Who has reviewed this research project?
Contact us
Who is conducting the study?
The D-Health trial is being conducted by a team of researchers at the QIMR Berghofer Medical Research Institute in collaboration with doctors and scientists around Australia. Collaborators include:
- QIMR Berghofer Medical Research Institute
- The University of Sydney
- Menzies Research Institute Tasmania
- Queensland University of Technology
- The University of Melbourne
- NHMRC Clinical Trials Centre
The study is being coordinated by Associate Professor Rachel Neale at the QIMR Berghofer Medical Research Institute and is funded by a research grant from the National Health and Medical Research Council (NHMRC) of Australia.
Why do a vitamin D trial?
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. D-Health is one of the largest trials of vitamin D in the world – we are aiming to recruit about 25,000 Australians aged 60-84. 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 we can give people correct advice in the future.
Who can take part?
We need 25,000 Australians aged 60-84 years. We are asking people to take part in one of two ways:
- Invitation letter: We have randomly selected some people from the Commonwealth Electoral Roll and invited them to take part. If you have received a letter and are interested in participating, please answer our questions to see if you are eligible.
- Heard about the study elsewhere: If you did not receive a letter and you are interested in taking part in D-Health, please contact us or call 1300 735 920
What will I be asked to do?
If you choose to take part in D-Health you will be:
- Randomly (by chance) assigned to take a tablet containing 60,000 international units (IU) of vitamin D or a placebo (‘neutral’ tablet*) on the first day of each month for up to 5 years. We will send you a text, email or phone reminder each month. You will not know which tablet you are taking.
- Asked to complete a short survey now and for each year that you are in the study.
You won't have to travel anywhere, it won't cost you any money and the time commitment is small.
It is possible that we may also ask you to complete additional surveys or talk to us on the phone so that we can gather detailed information about some specific health conditions. You won’t have to take part in these extra surveys if you don’t want to.
*A placebo is a medication with no active ingredients. It looks like the real thing but is not.
What are the benefits of taking part in the study?
You do not have to participate in the D-Health Trial, and taking part would not necessarily improve your health. The main benefit is the satisfaction of knowing that your participation in medical research could contribute to the improved health of future generations of Australians. You would not be paid but this contribution to society comes at no financial cost to you.
If you choose to take part each year you are in the trial you will have the opportunity to win one of six $200 Coles Group and Myer gift cards. We will draw one winner from each state each year and we will let you know if you’ve won.
What are the possible risks of taking part?
Vitamin D is a substance that occurs naturally in your body; you can also take it as a vitamin supplement. Too much vitamin D can cause the calcium levels in your body to become too high and this can lead to kidney stones, psychological and gastrointestinal and cardiovascular symptoms.
THE DOSES BEING USED HERE ARE WELL WITHIN SAFE LIMITS.
We are giving a dose of vitamin D that is equivalent to 2000 IU/day. The United States Institute of Medicine has said that you can safely take up to 10,000 IU/day without it causing problems, but to be cautious they suggest not going over 4000 IU/day. There have been studies that have safely given doses up to five times higher than we are using.
People generally take vitamin D tablets daily rather than monthly and you cannot buy a 60,000 IU tablet in Australia. This is therefore considered to be an experimental dose. Studies of the way vitamin D is metabolised in the body show that a large monthly dose does not cause vitamin D levels to become too high and is very good at maintaining enough vitamin D in the blood over the whole month. There is no evidence that taking a monthly dose carries a different risk to taking a daily dose. We have chosen to give a monthly dose because it is easier for you to remember to take. Other studies around the world are doing the same thing.
The tablets also contain soybean oil. Most people with soy allergy are not allergic to soybean oil because of the way it is processed. However if you have had a severe reaction to soy in the past you should not take part in the D-Health Trial. The outside shell of the tablet contains small
amounts of glycerol, gelatin and titanium dioxide.
How will D-Health find out details about participants' health?
An important component of this study is finding out information about participants' health. We will ask questions about participants' health in our annual surveys, but we would also like to obtain information from various other sources such as:
- Hospital and pathology records.
- Existing State and National Databases such as the Australian Cancer Database, state Cancer Registries, the National Death Index and other health databases, both public and private.
- Medicare and general practice information, Pharmaceutical Benefits Scheme and Repatriation Pharmaceutical Benefits Scheme.
What about confidentiality?
The D-Health Trial is bound by Commonwealth and State privacy legislation and must adhere to the guidelines of the National Health and Medical Research Council of Australia. All information collected will be treated confidentially and will be used for health research only.
All your information will be stored, analysed and reported with your identifying details removed. No information will be released in a way that would allow an individual or household to be identified, unless required by law. Any information obtained about you during this research project can be inspected by an authorised representative of the QIMR Berghofer Medical Research Institute during routine monitoring of D-Health.
Can participants take their own vitamin D tablets?
We understand that many people already take vitamin D or multivitamins that contain vitamin D, either because their doctor has recommended it or because they feel it will be good for their health. The current recommended daily intake (from foods AND supplements) for Australians is 600 IU per day, assuming no sun exposure. Most people get about 100 IU/day from food. If you take part in D-Health you can still take up to 500 IU per day (equivalent to a 1000 IU tablet every second day) as well as your study tablets.
Future research using my information
After you have taken part in D-Health we will keep the information that you give us indefinitely. It is possible that this information will be used for future studies of health. You will not receive any notice of future uses of this information, but any future studies that seek to use your information will have to be approved by the Scientific and Ethics committees at QIMR Berghofer (and, if applicable, the institution carrying out the analysis) before they can proceed. Any information given to other researchers will be identified by a code only so that it will never be possible for them to identify you.
Who has reviewed this project?
All research in Australia involving humans is reviewed by a Human Research Ethics Committee (HREC). The ethical aspects of this project have been reviewed by the HREC of the QIMR Berghofer Medical Research Institute.
Contact us
If you have any questions, comments or complaints about the study you can:
- Contact the D-Health helpline on 1300 735 920
- Email us at dhealth@qimrberghofer.edu.au
- Write to:
A/Prof Rachel Neale, D-Health Study
QIMR Berghofer Medical Research Institute
Locked Bag 2000, Royal Brisbane Hospital, QLD, 4029
If you have any concerns or complaints about the study you may also contact the chairperson of the QIMR Berghofer HREC via the Secretary (07 3362 0117).