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

Abstract We studied urinary riboflavin as an objective biomarker of compliance in clinical research using a simplified method amenable to high throughput analysis. Six healthy women not taking vitamin supplements ingested a study pill containing riboflavin (32 mg) as an inactive tracer and the soy isoflavones daidzin (0.243 mmole) and genistin (0.222 mmole) as active ingredients once daily for four days. Riboflavin and metabolites of the isoflavones were measured in urine samples obtained before and after each pill. Urinary excretion of riboflavin and metabolites of both isoflavones peaked within 8 hrs and remained higher than baseline for 24 hrs. Urinary excretion of riboflavin was also measured in 152 additional women with unrestricted dietary supplement intakes. Mean and median urinary riboflavin concentrations in these women were 0.42 and 0.31 μg/mL, respectively, compared to 0.2 μg/mL during a riboflavin-restricted diet. Receiver operating characteristics (ROC) curves indicated that urinary riboflavin within 24 hrs after a 32 mg dose would perform well as a measure of compliance (all areas under the ROC curves ≥0.84. Samples collected during the initial 8 hrs after pill ingestion performed better as a compliance measure than later collections. In summary, compliance in a clinical study can be monitored in real time by incorporating 32 mg of riboflavin into study pills, with compliance indicated by urinary riboflavin levels increasing over individual baselines or to ≥1.0 μg/mL, with a false positive rate of being classified as compliant at <5%.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title the open biomarkers journal
Publication Year Start




PMID- 21949554
OWN - NLM
STAT- Publisher
LR  - 20170919
IS  - 1875-3183 (Print)
VI  - 2011
IP  - 4
DP  - 2011
TI  - Riboflavin as an oral tracer for monitoring compliance in clinical research.
PG  - 1-7
AB  - We studied urinary riboflavin as an objective biomarker of compliance in clinical
      research using a simplified method amenable to high throughput analysis. Six
      healthy women not taking vitamin supplements ingested a study pill containing
      riboflavin (32 mg) as an inactive tracer and the soy isoflavones daidzin (0.243
      mmole) and genistin (0.222 mmole) as active ingredients once daily for four days.
      Riboflavin and metabolites of the isoflavones were measured in urine samples
      obtained before and after each pill. Urinary excretion of riboflavin and
      metabolites of both isoflavones peaked within 8 hrs and remained higher than
      baseline for 24 hrs. Urinary excretion of riboflavin was also measured in 152
      additional women with unrestricted dietary supplement intakes. Mean and median
      urinary riboflavin concentrations in these women were 0.42 and 0.31 mug/mL,
      respectively, compared to 0.2 mug/mL during a riboflavin-restricted diet.
      Receiver operating characteristics (ROC) curves indicated that urinary riboflavin
      within 24 hrs after a 32 mg dose would perform well as a measure of compliance
      (all areas under the ROC curves &gt;/=0.84. Samples collected during the initial 8
      hrs after pill ingestion performed better as a compliance measure than later
      collections. In summary, compliance in a clinical study can be monitored in real 
      time by incorporating 32 mg of riboflavin into study pills, with compliance
      indicated by urinary riboflavin levels increasing over individual baselines or to
      &gt;/=1.0 mug/mL, with a false positive rate of being classified as compliant at
      &lt;5%.
FAU - Ramanujam, V M Sadagopa
AU  - Ramanujam VM
AD  - Department of Preventive Medicine and Community Health, the University of Texas
      Medical Branch, Galveston, TX 77555-1109.
FAU - Anderson, Karl E
AU  - Anderson KE
FAU - Grady, James J
AU  - Grady JJ
FAU - Nayeem, Fatima
AU  - Nayeem F
FAU - Lu, Lee-Jane W
AU  - Lu LJ
LA  - eng
GR  - R01 CA095545-04/CA/NCI NIH HHS/United States
GR  - R01 CA095545-05S1/CA/NCI NIH HHS/United States
GR  - R01 CA095545-03/CA/NCI NIH HHS/United States
GR  - R01 CA095545-01A1S1/CA/NCI NIH HHS/United States
GR  - UL1 TR000071/TR/NCATS NIH HHS/United States
GR  - R01 CA095545/CA/NCI NIH HHS/United States
GR  - R01 CA095545-02/CA/NCI NIH HHS/United States
GR  - M01 RR000073/RR/NCRR NIH HHS/United States
GR  - R01 CA095545-06/CA/NCI NIH HHS/United States
GR  - R01 CA095545-01A1/CA/NCI NIH HHS/United States
GR  - R01 CA065628/CA/NCI NIH HHS/United States
GR  - R01 CA056273/CA/NCI NIH HHS/United States
GR  - P30 ES006676/ES/NIEHS NIH HHS/United States
GR  - R01 CA095545-05/CA/NCI NIH HHS/United States
GR  - UL1 RR029876/RR/NCRR NIH HHS/United States
PT  - Journal Article
PL  - Netherlands
TA  - Open Biomark J
JT  - The open biomarkers journal
JID - 101514551
PMC - PMC3176727
MID - NIHMS322332
EDAT- 2011/09/29 06:00
MHDA- 2011/09/29 06:00
CRDT- 2011/09/28 06:00
PHST- 2011/09/28 06:00 [entrez]
PHST- 2011/09/29 06:00 [pubmed]
PHST- 2011/09/29 06:00 [medline]
PST - ppublish
SO  - Open Biomark J. 2011;2011(4):1-7.