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

doi:10.1080/1354750X.2016.1269201

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

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

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.

Original language	English (US)
Pages (from-to)	508-516
Number of pages	9
Journal	Biomarkers
Volume	22
Issue number	6
DOIs	https://doi.org/10.1080/1354750X.2016.1269201
State	Published - Aug 18 2017

Keywords

Biomarker
accuracy
adherence
clinical trial
daidzein
genistein
medication compliance
receiver operating curve
riboflavin
sensitivity
specificity

ASJC Scopus subject areas

Biochemistry
Clinical Biochemistry
Health, Toxicology and Mutagenesis

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10.1080/1354750X.2016.1269201

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

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.",

keywords = "Biomarker, accuracy, adherence, clinical trial, daidzein, genistein, medication compliance, receiver operating curve, riboflavin, sensitivity, specificity",

author = "Ramanujam, {V. M.S.} and Fatima Nayeem and Anderson, {Karl E.} and Kuo, {Yong Fang} and Chen, {Nai Wei} and Hyunsu Ju and Lu, {Lee Jane W.}",

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T1 - Riboflavin as an independent and accurate biomarker for adherence in a randomized double-blind and placebo-controlled clinical trial

AU - Ramanujam, V. M.S.

AU - Nayeem, Fatima

AU - Anderson, Karl E.

AU - Kuo, Yong Fang

AU - Chen, Nai Wei

AU - Ju, Hyunsu

AU - Lu, Lee Jane W.

PY - 2017/8/18

Y1 - 2017/8/18

N2 - 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.

AB - 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.

KW - Biomarker

KW - accuracy

KW - adherence

KW - clinical trial

KW - daidzein

KW - genistein

KW - medication compliance

KW - receiver operating curve

KW - riboflavin

KW - sensitivity

KW - specificity

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ER -

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

Abstract

Keywords

ASJC Scopus subject areas

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