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

V-M S Ramanujam, Fatima Nayeem, Karl E Anderson, Yong-Fang Kuo, Nai-Wei Chen, Hyunsu Ju, Lee-Jane W Lu

Biomarkers : Biochemical Indicators of Exposure, Response, and Susceptibility to Chemicals 2017 September

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.

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