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

V-M Ramanujam, Fatima Nayeem, Karl Anderson, Yong Fang Kuo, Nai Wei Chen, Hyunsu Ju, Leejane Lu

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)1-9
Number of pages9
JournalBiomarkers
DOIs
StateAccepted/In press - Dec 22 2016

Fingerprint

Riboflavin
Controlled Clinical Trials
Biomarkers
Placebos
Clinical Trials
Medication Adherence
Genistein
Classifiers
Eating
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Health, Toxicology and Mutagenesis

Cite this

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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.",
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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

AU - Nayeem, Fatima

AU - Anderson, Karl

AU - Kuo, Yong Fang

AU - Chen, Nai Wei

AU - Ju, Hyunsu

AU - Lu, Leejane

PY - 2016/12/22

Y1 - 2016/12/22

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.

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