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

4 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

Access to Document

10.1080/1354750X.2016.1269201

Cite this

@article{8e4eca8629444981b6839f65352bdc01,

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.\}",

note = "Publisher Copyright: {\textcopyright} 2016 Informa UK Limited, trading as Taylor \& Francis Group.",

year = "2017",

month = aug,

day = "18",

doi = "10.1080/1354750X.2016.1269201",

language = "English (US)",

volume = "22",

pages = "508--516",

journal = "Biomarkers",

issn = "1354-750X",

publisher = "Taylor and Francis Ltd.",

number = "6",

}

TY - JOUR

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

UR - https://www.scopus.com/pages/publications/85007196083

UR - https://www.scopus.com/inward/citedby.url?scp=85007196083&partnerID=8YFLogxK

U2 - 10.1080/1354750X.2016.1269201

DO - 10.1080/1354750X.2016.1269201

M3 - Article

C2 - 27918196

AN - SCOPUS:85007196083

SN - 1354-750X

VL - 22

SP - 508

EP - 516

JO - Biomarkers

JF - Biomarkers

IS - 6

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

Access to Document

Other files and links

Fingerprint

Cite this