Adherence Assessment for Supplements

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DESCRIPTION (provided by applicant): The use of dietary supplements has become increasingly popular in the US, and these supplements are not subject to stringent pre-marketing testing or post-marketing surveillance. More than a 1/3rd of American adults report using some form of CAM, with total visits to CAM providers each year now exceeding those to primary-care physicians. An estimated 15 million adults take herbal remedies or high-dose vitamins along with prescription drugs. NCCAM studies are designed in scientifically rigorous manners and patients are monitored for product usage. However, measuring biological markers and metabolites would greatly benefit the accuracy and reliability of data. NCCAM has requested the development of "common methods, measures, and standards for the generation and interpretation of evidence necessary for making decisions about the use of CAM and conventional therapies."Caldera Pharmaceuticals will develop a new technology to objectively assess patient adherence to the use of complementary and alternative medicines (CAMs). Caldera proposes to develop and optimize technology that will capture, in minimally invasive and objective ways, adherence to certain CAMs in ambulatory and clinical settings, and from a range of patient groups engaging in intervention strategies. Caldera anticipates that these tools will be particularly relevant to commonly used mineral supplements (such as chromium picolinate, magnesium sulfate, and organic and inorganic selenium), but will eventually address adherence to other CAMs. This project will use Reagentless Pharmacoproteomic Measurement (RPM), a technique that uses X-ray fluorescence to quantify the binding of metals to proteins. RPM can be used to identify and quantify biologically active CAM agents and their metabolites in body fluids. Caldera will tailor and optimize its unique RPM technology to specifically measure patient adherence in CAM studies. Phase I consists of using RPM to measure metal content of proteins in a yeast model. Phase II consists of using RPM to measure CAM adherence using biological specimens from existing CAM clinical trials to benchmark this technique. More than a 1/3rd of American adults report using some form of complementary and alternative medicines (CAM), with total visits to CAM providers each year now exceeding those to primary-care physicians. NCCAM has requested the development of common methods for the generation and interpretation of evidence necessary for making decisions about the use of CAM and conventional therapies. Caldera Pharmaceutical will develop technology to objectively assess patient adherence to the use of CAM.