Expand and collapse the following frequently asked questions below by clicking on them:
Side Effects & Risks
- What are the risks of the study?
- While on the study, you may be at risk for the side effects listed below. You should
discuss these with the Study Site staff and/or your regular doctor. There also may be other side effects
that we cannot predict. Many side effects go away shortly after the Study Supplements are stopped.
In some cases side effects can be serious or long lasting or permanent.
Most people believe that vitamins and food supplements have few and mild side effects. However, the
doses used in SELECT are higher than the recommended daily requirements for selenium and vitamin E.
selenium:
Selenium is found in many foods. The dose of selenium for SELECT is not expected to cause you any side
effects. However, long term use of selenium at higher doses has been known to cause mild nausea, garlic
breath (or "bad breath"), hair or nail changes, cough (symptoms of the common cold), bronchitis, dizziness,
weakness, skin redness or rash, irritability and tiredness. One study did report an increased risk of
non-melanoma skin cancer (particularly squamous cell skin cancer) with selenium use in patients who had
previously had this disease. Removing selenium supplementation can reverse side effects. There may
also be other side effects that we cannot predict.
vitamin E:
No serious side effects have been linked to the use of vitamin E in the doses used for SELECT. One study
did report an increased risk of stroke among male smokers taking this vitamin; however, this risk was seen
only in male smokers who already had uncontrolled high blood pressure.
Combination:
Based on prior studies, the combination of selenium and vitamin E is not expected to cause extra side effects.
We do not expect different side effects or more frequent or severe side effects than with each supplement
given alone. As with the use of selenium and vitamin E alone, there also may be side effects from the
combination that we cannot predict.
Placebo:
The placebo does not contain any active ingredients. These Study Supplements will look just like the Study
Supplements containing vitamin E or the Study Supplements containing selenium; however, there should not be
any side effects. The selenium-matched Study Supplements contain an inactive filler (dicalcium phosphate)
and the vitamin E-matched Study Supplements contain soybean oil.
If you have any difficulty taking soybean products, please discuss this with your doctor.
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- How are emergencies handled?
- If you have a true medical emergency, you should call 911. If the situation isn't truly urgent,
contact your doctor and your SELECT Study Site. All of your concerns are important and will be handled in a way
that protects your health and well being.
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- Could I be allergic to the study supplements?
- It is unlikely that you would be allergic to the supplements. But if you think you are having an
allergic reaction to the supplements, please contact your doctor and your SELECT Study Site.
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- What is a study supplement holiday?
- A Study Supplement holiday is a period of time that you quit taking the supplements,
with the expectation that you will take them again at a later time. It might be appropriate for you to
take a Study Supplement holiday for the following reasons:
- You experience a reaction that may be caused by the Study Supplements. In this case you would stop taking
the Study Supplements and then see if the reaction goes away.
- You need time to consider whether or not to continue taking the Study Supplements, and if you want to
continue being a part of the study.
- You are receiving treatments that may interact with the Study Supplements. For example, blood thinners
may interact with vitamin E.
Please discuss with the Study Staff whether or not you should take a Study Supplement holiday.
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