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Riboflavin as an independent and accurate biomarker for adherence in a randomized double-blind and placebo-controlled clinical trial |
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| Authors: | V-M. S. Ramanujam Fatima Nayeem Karl E. Anderson Yong-Fang Kuo Nai-Wei Chen Hyunsu Ju |
| Affiliation: | Department of Preventive Medicine and Community Health, The University of Texas Medical Branch, Galveston, TX, USA |
| Abstract: | Background: Medication adherence is critical for success of clinical trials. Objective: To assess oral riboflavin is an adherence marker. Methods: Riboflavin was incorporated into active treatment and placebo pills for a clinical trial lasting for 2 years. Results: The accuracy (area under the receiver operating curve) of urinary riboflavin was 0.91 as a binary classifier of adherence, and was similar or better than for two active study ingredients daidzein (0.92) and genistein (0.87) (all p? Conclusion: Riboflavin is an accurate and useful biomarker for study pill ingestion. |
| Keywords: | Biomarker medication compliance adherence clinical trial riboflavin daidzein genistein receiver operating curve sensitivity specificity accuracy |