rct
    2005

    A phase I study of indole-3-carbinol in women: tolerability and effects on estrogen metabolism

    Reed GA, Peterson KS, Smith HJ, Gray JC, Sullivan DK, Mayo MS, Crowell JA, Hurwitz A

    Published in Cancer Epidemiology, Biomarkers & Prevention

    Methodology

    Single-dose escalation and multiple-dose phase I study of indole-3-carbinol in healthy women measuring pharmacokinetics and urinary estrogen metabolites

    Key Findings

    Indole-3-carbinol was well tolerated up to 400 mg twice daily and increased the 2-hydroxyestrone to 16-alpha-hydroxyestrone ratio.

    Conclusions

    Indole-3-carbinol shifts estrogen metabolism toward 2-hydroxylation at tolerable doses.

    Limitations

    Small phase I design; surrogate biomarker endpoint; no disease outcomes.

    Supplements Studied

    Indole-3-carbinol was well tolerated up to 400 mg twice daily and increased the 2-hydroxyestrone to 16-alpha-hydroxyestrone ratio.

    Outcomes Measured

    Indole-3-carbinol increased the 2-hydroxyestrone to 16-alpha-hydroxyestrone ratio.

    Study Details

    Year:2005
    Sample Size:20
    Duration:4 weeks
    Quality Score:6/10

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