Randomised trial · JAMA · 2011

Vitamin E supplements and prostate cancer risk in healthy men

What it found

In a large trial of healthy men, those who took vitamin E supplements had a higher rate of prostate cancer than those who took a placebo.

The increase was small but the authors say it was not likely due to chance.

What they found

Studies in people

Prostate cancer risk

Men who took vitamin E alone had a higher rate of prostate cancer than those on placebo. The difference became apparent during the third year and grew slightly each year after.

Selenium and combination

The selenium alone and selenium plus vitamin E groups also had slightly more prostate cancers than placebo, but the differences were not statistically significant.

Absolute risk increase

Compared with placebo, the extra number of prostate cancer cases per 1,000 person-years was 1.6 for vitamin E, 0.9 for selenium, and 0.4 for the combination.

Aggressive cancer

The risk of Gleason 7 or higher prostate cancer was higher in all three supplement groups, but the differences did not reach statistical significance.

Other health outcomes

There were no significant differences between groups in overall survival, lung cancer, colorectal cancer, other cancers, deaths, or serious cardiovascular events.

Type 2 diabetes

The earlier signal of increased type 2 diabetes in the selenium group became weaker with longer follow-up and was not statistically significant.

What the authors conclude

“Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men.”
Klein EA, Thompson IM, Tangen CM, et al, 2011

Also in their conclusions

  • They conclude that dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men.
  • They advise that caution should be used when recommending or studying high doses of micronutrients.
  • They state that consumers should be skeptical of health claims for unregulated over-the-counter products in the absence of strong evidence of benefit from clinical trials.

How it was done

Earlier lab and population studies suggested that selenium and vitamin E might lower the risk of prostate cancer. The authors ran this trial to test whether these supplements could prevent prostate cancer in men at average risk.

They randomly assigned 35,533 men from 427 sites in the United States, Canada, and Puerto Rico to one of four groups: selenium alone, vitamin E alone, both, or placebo. The men took the supplements or placebo for a planned follow-up of at least 7 and up to 12 years. The main outcome was whether they developed prostate cancer.

What it can’t tell you

  • This trial was in men at average risk of prostate cancer, so the results may not apply to other groups.
  • The trial cannot show why vitamin E might increase prostate cancer risk; the authors say a biological explanation is not apparent from these data.

The paper

Title
Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT)
Type
Randomised controlled trial
Evidence
Studies in people
Summarised from
Full text
Cite
Klein EA, Thompson IM, Tangen CM, et al (2011). Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. doi:10.1001/jama.2011.1437Free full textPubMed 21990298DOI

Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error