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Risk of prostate cancer in a randomized clinical trial of calcium supplementation.

Abstract

BACKGROUND

In some studies, high calcium intake has been associated with an increased risk of prostate cancer, but no randomized studies have investigated this issue.

METHODS

We randomly assigned 672 men to receive either 3 g of calcium carbonate (1,200 mg of calcium), or placebo, daily for 4 years in a colorectal adenoma chemoprevention trial. Participants were followed for up to 12 years and asked periodically to report new cancer diagnoses. Subject reports were verified by medical record review. Serum samples, collected at randomization and after 4 years, were analyzed for 1,25-(OH)2 vitamin D, 25-(OH) vitamin D, and prostate-specific antigen (PSA). We used life table and Cox proportional hazard models to compute rate ratios for prostate cancer incidence and generalized linear models to assess the relative risk of increases in PSA levels.

RESULTS

After a mean follow-up of 10.3 years, there were 33 prostate cancer cases in the calcium-treated group and 37 in the placebo-treated group [unadjusted rate ratio, 0.83; 95% confidence interval (95% CI), 0.52-1.32]. Most cases were not advanced; the mean Gleason's score was 6.2. During the first 6 years (until 2 years post-treatment), there were significantly fewer cases in the calcium group (unadjusted rate ratio, 0.52; 95% CI, 0.28-0.98). The calcium risk ratio for conversion to PSA >4.0 ng/mL was 0.63 (95% CI, 0.33-1.21). Baseline dietary calcium intake, plasma 1,25-(OH)2 vitamin D and 25-(OH) vitamin D levels were not materially associated with risk.

CONCLUSION

In this randomized controlled clinical trial, there was no increase in prostate cancer risk associated with calcium supplementation and some suggestion of a protective effect.

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  • Authors+Show Affiliations

    ,

    Department of Medicine, Dartmouth Medical School, Hanover, New Hampshire, USA.

    , , , , , ,

    Source

    MeSH

    Adenoma
    Aged
    Antacids
    Calcium Carbonate
    Colorectal Neoplasms
    Dietary Supplements
    Humans
    Male
    Middle Aged
    Odds Ratio
    Placebos
    Prostatic Neoplasms
    Risk Factors
    Vitamin D

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    15767334

    Citation

    Baron, John A., et al. "Risk of Prostate Cancer in a Randomized Clinical Trial of Calcium Supplementation." Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored By the American Society of Preventive Oncology, vol. 14, no. 3, 2005, pp. 586-9.
    Baron JA, Beach M, Wallace K, et al. Risk of prostate cancer in a randomized clinical trial of calcium supplementation. Cancer Epidemiol Biomarkers Prev. 2005;14(3):586-9.
    Baron, J. A., Beach, M., Wallace, K., Grau, M. V., Sandler, R. S., Mandel, J. S., ... Greenberg, E. R. (2005). Risk of prostate cancer in a randomized clinical trial of calcium supplementation. Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored By the American Society of Preventive Oncology, 14(3), pp. 586-9.
    Baron JA, et al. Risk of Prostate Cancer in a Randomized Clinical Trial of Calcium Supplementation. Cancer Epidemiol Biomarkers Prev. 2005;14(3):586-9. PubMed PMID: 15767334.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Risk of prostate cancer in a randomized clinical trial of calcium supplementation. AU - Baron,John A, AU - Beach,Michael, AU - Wallace,Kristin, AU - Grau,Maria V, AU - Sandler,Robert S, AU - Mandel,Jack S, AU - Heber,David, AU - Greenberg,E Robert, PY - 2005/3/16/pubmed PY - 2005/7/26/medline PY - 2005/3/16/entrez SP - 586 EP - 9 JF - Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology JO - Cancer Epidemiol. Biomarkers Prev. VL - 14 IS - 3 N2 - BACKGROUND: In some studies, high calcium intake has been associated with an increased risk of prostate cancer, but no randomized studies have investigated this issue. METHODS: We randomly assigned 672 men to receive either 3 g of calcium carbonate (1,200 mg of calcium), or placebo, daily for 4 years in a colorectal adenoma chemoprevention trial. Participants were followed for up to 12 years and asked periodically to report new cancer diagnoses. Subject reports were verified by medical record review. Serum samples, collected at randomization and after 4 years, were analyzed for 1,25-(OH)2 vitamin D, 25-(OH) vitamin D, and prostate-specific antigen (PSA). We used life table and Cox proportional hazard models to compute rate ratios for prostate cancer incidence and generalized linear models to assess the relative risk of increases in PSA levels. RESULTS: After a mean follow-up of 10.3 years, there were 33 prostate cancer cases in the calcium-treated group and 37 in the placebo-treated group [unadjusted rate ratio, 0.83; 95% confidence interval (95% CI), 0.52-1.32]. Most cases were not advanced; the mean Gleason's score was 6.2. During the first 6 years (until 2 years post-treatment), there were significantly fewer cases in the calcium group (unadjusted rate ratio, 0.52; 95% CI, 0.28-0.98). The calcium risk ratio for conversion to PSA >4.0 ng/mL was 0.63 (95% CI, 0.33-1.21). Baseline dietary calcium intake, plasma 1,25-(OH)2 vitamin D and 25-(OH) vitamin D levels were not materially associated with risk. CONCLUSION: In this randomized controlled clinical trial, there was no increase in prostate cancer risk associated with calcium supplementation and some suggestion of a protective effect. SN - 1055-9965 UR - https://www.unboundmedicine.com/medline/citation/15767334/full_citation L2 - http://cebp.aacrjournals.org/cgi/pmidlookup?view=long&pmid=15767334 DB - PRIME DP - Unbound Medicine ER -