What are the drugs that I'm taking?
You will be given tablets and liquid drops. The tablets are either Aspirin or placebo (a ‘dummy’ drug), and the drops are either Vitamin D3 or a placebo. You won’t know whether you’re taking the real drugs or the placebo, as they look and taste identical.
The exact possibilities are: Tablets (one of the following):
- 100mg Aspirin
- 300mg Aspirin
- Aspirin placebo
Liquid drops (one of the following):
- Vitamin D3 oil
- Placebo oil
How should I take my tablets?
Take one tablet a day, preferably in the morning. Swallow it whole with a glass of water and food. It’s important that you don’t crush the tablet, as its coating protects the lining of your stomach.
How should I take my liquid drops?
Take eight drops a day, either from a teaspoon or by dropping them onto a piece of bread to be eaten. Please avoid adding the drops to a drink because some of the oil may stick to the side of the cup, meaning you won’t take in the whole dose.
Where should I store my drugs?
Keep the tablets and the liquid drops in their original containers in a cool dry place, away from heat sources and direct sunlight. The tablets are provided in child-proof containers, and should be kept out of reach of children. Do not keep the liquid drops in the fridge, as the oil changes consistency if it becomes too cool.
What should I do with the empty drug containers?
It’s important that you keep these, and give them back to your study doctor/nurse
Can I take other drugs during the study?
Tell your study doctor/nurse about any existing or new medication you’re taking, including non-prescription drugs. While taking your PROVENT Aspirin you must not take anything else containing Aspirin (e.g. some flu remedies), without consulting your doctor first, due to the risk of bleeding. You should also avoid other drugs in the same family as Aspirin (NSAIDS). These include ibuprofen, naproxen and indomethacin, and are often used to treat pain and arthritis. If you’re unsure about anything you’re taking, check with your doctor. If you have pain or a fever, we recommend taking paracetamol. Avoid any additional Vitamin D, or Vitamin supplements containing Vitamin D.
Who should I tell about the drugs that I’m taking?
We will tell your GP that you’re taking part in PROVENT, but always remind him/her when you visit. Also inform any other doctor, nurse or dentist who treats you. They should assume that you’re on the maximum daily dose of Aspirin (300mg) and Vitamin D3 (4000IU).
Should I ever stop taking my PROVENT drugs during the study?
You must stop taking the Aspirin tablets 7 days before any surgery that you know about in advance (e.g. your annual prostate biopsy). If you develop any new symptoms of indigestion during the trial, please contact your study doctor/nurse for advice. If the indigestion is severe or you have stomach pains or signs of bleeding, stop taking the tablets and contact your study centre. In case of an emergency, contact a doctor or go to a hospital immediately.
What if I lose my drugs?
Contact your study centre. They will arrange for replacement supplies to be delivered to the hospital pharmacy for you to collect.
What if I forget my tablet?
You can take your tablet later that same day as long as it’s more than six hours before your next dose is due. Do not take more than two tablets in 24 hours. If there’s not enough time before your next dose to take the missed tablet, skip it and record it on your diary card.
What if I forget my liquid drops?
You can take the dose at any time. It’s safe to take two doses together, but don’t take more than two at once. Record delayed doses on your diary card.
What if I take too many tablets, or someone else takes my tablets?
2 tablets: This is unlikely to be dangerous. Make a note on your diary card, and be alert for any unusual symptoms. If you have a problem, contact your study centre or GP.
2-5 tablets: The appropriate action depends on how many tablets were taken. Contact your study centre, GP or local hospital for advice.
5+ tablets: Contact a doctor or go to a hospital immediately. Take the tablet packet and your diary card with you, so the doctor knows what may have been taken.
Children: If a child has taken any of your tablets, take them to a hospital immediately.
What if I take too many liquid drops?
8-12 drops: This is unlikely to be dangerous.
12+ drops: This is unlikely to cause any major short-term side effects, but a large amount of Vitamin D could alter the calcium levels in your blood. You should report this to your study centre or your doctor, who will be able to give you advice and monitor your calcium levels.