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Riboflavin as an independent and accurate biomarker for adherence in a randomized double-blind and placebo-controlled clinical trial

Year: 2016
Type: article
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 < 0.0001). Decreased adherence over time was similar in the two study groups. CONCLUSION: Riboflavin is an accurate and useful biomarker for study pill ingestion.
Source: Biomarkers
DOI: 10.1080/1354750x.2016.1269201
Authors: V-M. S. Ramanujam, Fatima Nayeem, Karl E. Anderson, Yong-Fang Kuo, Nai-Wei Chen, Hyunsu Ju, Lee-Jane W. Lu
Language: English
Subfield: Family Practice
Field: Medicine
Open Access status: green
Funders: Institute of Translational Health Sciences, National Institutes of Health, National Cancer Institute, National Institute of Environmental Health Sciences, National Center for Research Resources, National Center for Advancing Translational Sciences
Awards: Cellular Response Mechanisms to Environmental Challenge, G2432115572, G2950624264, G3835834548, G3897601846, Mammographic Density and Soy Isoflavones, UTMB Clinical and Translational Science Award, UTMB Clinical and Translational Science Award, General Clinical Research Center, UTMB Clinical and Translational Science Award
OpenAlex ID: W2560203188
FWCI: 1.219
Cites: 56
Cited by: 7
Related to: 10