Sponsor study identifier
observational
27
1 country
1
Study Start
February 1, 2012
Actual (reported)Primary Completion
January 31, 2017
Actual (reported)Study Completion
January 31, 2017
Actual (reported)Minimal human data exist on actual liver vitamin A compared with blood biomarkers. One blood biomarker, the percent of total serum retinol (vitamin A) in the form of retinyl esters, has been suggested to diagnose hypervitaminosis A with cutoffs of 5% and 10%. In this study, investigators aim to compare total liver vitamin A reserves with the percent total serum retinol as retinyl esters to evaluate hypervitaminosis A using autopsy samples from US adults. Investigators also evaluate the sensitivity (the ability of the biomarker to correctly identify those with deficiency) and specificity (the ability of the biomarker to correctly identify those without deficiency) of serum retinol to determine vitamin A deficiency, variation of liver vitamin A concentration among lobes, and liver alpha retinyl ester concentrations, a cleavage product of alpha-carotene, a vitamin A precursor. To conduct the study, matched serum and liver samples were procured from 27 US adult cadavers (from donors age 49-101 years) and their vitamin A biomarkers were analyzed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2012
Actual (reported)January 31, 2017
Actual (reported)January 31, 2017
Actual (reported)September 29, 2017
Actual (reported)October 9, 2017
Actual (reported)Serum retinyl esters, nmol/L
Concentration of retinyl esters in subjects' serum
Enrollment
Liver vitamin A reserves, µmol/g
Concentration of vitamin A in subjects' liver samples
Enrollment
Serum retinol, µmol/L
Enrollment
Liver alpha-retinyl ester, nmol/g
Enrollment
Ages 21-54 y
Ages 55-74 y
Age \>75 y
US adult cadavers from the the National Disease Research Interchange service age 21 years and older, death from any cause.
University of Wisconsin - Madison
Madison, Wisconsin, 53706, United States
Olsen K, Suri DJ, Davis C, Sheftel J, Nishimoto K, Yamaoka Y, Toya Y, Welham NV, Tanumihardjo SA. Serum retinyl esters are positively correlated with analyzed total liver vitamin A reserves collected from US adults at time of death. Am J Clin Nutr. 2018 Nov 1;108(5):997-1005. doi: 10.1093/ajcn/nqy190.
Serum and liver samples
27 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2017
First Posted
October 9, 2017
Study Start
February 1, 2012
Actual (reported)Vitamin A Equivalence of Plant Carotenoids in Children
Contact the study team to confirm eligibility.
Primary Completion
January 31, 2017
Actual (reported)Study Completion
January 31, 2017
Actual (reported)Last Updated
October 17, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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