Literature DB >> 27918196

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

V-M S Ramanujam1, Fatima Nayeem1, Karl E Anderson1, Yong-Fang Kuo1, Nai-Wei Chen1, Hyunsu Ju1, Lee-Jane W Lu1.   

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.

Entities:  

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

Mesh：

Substances：

Year:  2016        PMID： 27918196      PMCID： PMC5613754          DOI： 10.1080/1354750X.2016.1269201

Source DB:  PubMed          Journal:  Biomarkers        ISSN： 1354-750X            Impact factor:   2.658


  49 in total

1.  Riboflavin as an oral tracer for monitoring compliance in clinical research.

Authors:  V M Sadagopa Ramanujam; Karl E Anderson; James J Grady; Fatima Nayeem; Lee-Jane W Lu
Journal:  Open Biomark J       Date:  2011

2.  Altered kinetics and extent of urinary daidzein and genistein excretion in women during chronic soya exposure.

Authors:  L J Lu; S N Lin; J J Grady; M Nagamani; K E Anderson
Journal:  Nutr Cancer       Date:  1996       Impact factor: 2.900

3.  Tracer microspheres as compliance markers in clinical research.

Authors:  R L Wolen; R E Crabtree; R H Carmichael
Journal:  Control Clin Trials       Date:  1984-12

4.  Platelet-activating factor stimulation of tyrosine kinase and its relationship to phospholipase C in rabbit platelets: studies with genistein and monoclonal antibody to phosphotyrosine.

Authors:  A Dhar; A K Paul; S D Shukla
Journal:  Mol Pharmacol       Date:  1990-04       Impact factor: 4.436

5.  A simplified method to quantify isoflavones in commercial soybean diets and human urine after legume consumption.

Authors:  L J Lu; L D Broemeling; M V Marshall; V M Ramanujam
Journal:  Cancer Epidemiol Biomarkers Prev       Date:  1995 Jul-Aug       Impact factor: 4.254

6.  Disulfiram treatment of alcoholism. A Veterans Administration cooperative study.

Authors:  R K Fuller; L Branchey; D R Brightwell; R M Derman; C D Emrick; F L Iber; K E James; R B Lacoursiere; K K Lee; I Lowenstam
Journal:  JAMA       Date:  1986-09-19       Impact factor: 56.272

7.  Efficacy of disulfiram and cognitive behavior therapy in cocaine-dependent outpatients: a randomized placebo-controlled trial.

Authors:  Kathleen M Carroll; Lisa R Fenton; Samuel A Ball; Charla Nich; Tami L Frankforter; Julia Shi; Bruce J Rounsaville
Journal:  Arch Gen Psychiatry       Date:  2004-03

8.  Methods for measuring, enhancing, and accounting for medication adherence in clinical trials.

Authors:  B Vrijens; J Urquhart
Journal:  Clin Pharmacol Ther       Date:  2014-03-12       Impact factor: 6.875

Review 9.  Medication adherence: its importance in cardiovascular outcomes.

Authors:  P Michael Ho; Chris L Bryson; John S Rumsfeld
Journal:  Circulation       Date:  2009-06-16       Impact factor: 29.690

10.  Dietary estrogens stimulate human breast cells to enter the cell cycle.

Authors:  C Dees; J S Foster; S Ahamed; J Wimalasena
Journal:  Environ Health Perspect       Date:  1997-04       Impact factor: 9.031
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  3 in total

1.  Daidzein and genistein have differential effects in decreasing whole body bone mineral density but had no effect on hip and spine density in premenopausal women: A 2-year randomized, double-blind, placebo-controlled study.

Authors:  Fatima Nayeem; Nai-Wei Chen; Manubai Nagamani; Karl E Anderson; Lee-Jane W Lu
Journal:  Nutr Res       Date:  2019-07-03       Impact factor: 3.315

2.  Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study.

Authors:  Lee-Jane W Lu; Nai-Wei Chen; Fatima Nayeem; V-M Sadagopa Ramanujam; Yong-Fang Kuo; Donald G Brunder; Manubai Nagamani; Karl E Anderson
Journal:  Clin Nutr       Date:  2017-11-11       Impact factor: 7.324

3.  Soy isoflavones interact with calcium and contribute to blood pressure homeostasis in women: a randomized, double-blind, placebo controlled trial.

Authors:  Lee-Jane W Lu; Nai-Wei Chen; Fatima Nayeem; Manubai Nagamani; Karl E Anderson
Journal:  Eur J Nutr       Date:  2019-09-18       Impact factor: 5.614
  3 in total

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