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CompletedNCT03305042Updated Oct 17, 2017

Vitamin A Liver Reserves and Serum Markers of Vitamin A in US Adults at Time of Death

An observational study in Vitamin A Deficiency and Vitamin A Toxicity, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-17.

Sponsored by University of Wisconsin, Madison · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
27
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Vitamin A Deficiency with a site in United States — 5 open to participants now, 6 under way, 1 of them phase 3. Vitamin A Deficiency · United States.

Started
2012
the only one that year
Observational
4 of 16
none open now
Registered
8th of 16
by date
Lead sponsor
3 of 16
University of Wisconsin, Madison

Among the 16 studies in Vitamin A Deficiency with a site in United States, this one is the only one that started in 2012, is one of 4 observational ones, and was the 8th registered.

Vitamin A Deficiency

67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.

Browse Vitamin A Deficiency studies →

Open to participants now

5 of the 16 studies in Vitamin A Deficiency with a site in United States are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 6 Vitamin A Deficiency studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 21 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Vitamin A Deficiency with a site in United States, or all of them as a file.
02

Study summary

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.

Read the detailed description

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. Matched human liver and serum samples were collected from 27 cadavers, 13 male and 14 female, and acquired as a consecutive sample through a request to the National Disease Research Interchange service. De-identified clinical history summaries were also obtained. The donor criteria were as follows: no restrictions on race or sex, no history of chemotherapy and/or radiation, no history of prolonged endotracheal intubation or ventilation, no evidence of sepsis or infectious disease (negative serology panel), and age ranges of 21-54 y, 55-74 y, and >75 y (target collection was 5 male and 5 female donors per age range to provide a non-homogenous sample). After 10 individuals were acquired in each age range (i.e., 55-74 y and >75 y), samples were no longer requested. All tissues and sera were procured within 16 h post-mortem from September 2013 through August 2016. The procurement protocol numbers were DWEN1 002 022, 002 023, and 002 024 for frozen liver, embedded liver, and serum, respectively. Serum samples were isolated via gel separation and then frozen; primary liver samples were snap frozen in liquid N2; a second liver sample from each donor was embedded in optimal cutting temperature compound (OCT) and snap frozen in a cryomold. Two livers were procured almost whole and evaluated for VA distribution within and among lobes. Samples were shipped on dry ice to Madison, WI, and stored in a -80°C freezer.

OCT-embedded liver samples were prepared as 5-µm frozen sections using a cryostat and stained using routine hematoxylin and eosin and Masson's trichrome protocols and reagents (Newcomer Supply, Middleton, WI). Images were captured using a Nikon E-600 bright field microscope (Melville, NY) and Olympus DP-71 digital microscopy camera (Center Valley, PA). Liver samples (1 g) for VA and carotenoid analyses were weighed and then ground with sodium sulfate (4-5 g) in a mortar and pestle using published methods with minor modifications. Purified C-23 beta-apo-carotenol was added to determine extraction efficiencies. Samples were extracted repeatedly with dichloromethane and filtered through WhatmanTM #1 (GE Healthcare Life Sciences, Pittsburgh, PA) into 50-mL volumetric flasks. An aliquot (5 mL) was dried under nitrogen, re-dissolved in 300 µL methanol:dichloroethane (75:25, volume:volume) and an aliquot of 1 µL was injected into a Waters Acquity H-Class ultra-pressure liquid chromatograph (UPLC®) system equipped with a photodiode array detector (Milford, MA). Aliquots were further saponified for quantification of total alpha-retinol as described below for the lobe analyses. For the liver lobe sample evaluations, 1 g samples were extracted in triplicate from each available lobe. A 5-mL aliquot of the extract was saponified with 400 mL potassium hydroxide:water (50:50, weight:volume) at 45°C for 1 h. The reaction was quenched with 0.5 mL water and extracted three times with 0.5 mL hexanes. The hexane layers were pooled and dried under nitrogen, redissolved in 150 µL methanol:dichloroethane (75:25, volume:volume), and an aliquot of 1 µL was injected into the UPLC® system.

Serum samples (0.5 mL) were aliquoted into test tubes for retinol and RE determination; 1.25 X volume of ethanol was added to denature proteins. The internal standard was C23-β-apo-carotenol. Samples were extracted three times with 0.75 mL hexanes; the supernatant fractions were pooled and dried under nitrogen and reconstituted in 100 µL methanol: dichloroethane (75:25, volume:volume). Two µL was injected into the UPLC® under the conditions described below. Serum C-reactive protein (CRP) and alpha1-acid glycoprotein (AGP) were analyzed to evaluate inflammation using ELISA kits (CRP: Cayman Chemical Company; AGP: Abcam). Lycopene and alpha- and beta-carotene concentrations were determined by routine HPLC analysis.

Ultra-high Performance Liquid Chromatograph (UPLC) method A Waters Acquity UPLC HSS C18 1.8 µm VanGuard pre-column was used in conjunction with a Waters Acquity UPLC® HSS C18 column (1.8 µm, 2.1 x 150 mm). The method utilized two solvent mixes programmed for a 29-min gradient. Solvent A was acetonitrile-water-isopropanol (70:25:5, volume:volume:volume) with 10 mmol/L ammonium acetate and solvent B was methanol-isopropanol (75:25, volume:volume). The column temperature was set to 32°C and flow rate was 0.4 mL/min. The gradient began by holding 100% solvent A for 7 min, followed by a 4-min linear transition to 5% A, and another transition to 1% A over 12 min. The solvent gradient was then reversed to 100% A in 2 min and equilibrated for 4 min. Chromatograms were generated at 311 nm for α-retinol and α-REs, 325 nm for retinol and REs, and 450 nm for carotenoids. alpha-REs, derived almost exclusively from beta-carotene in the diet, were quantified as a proxy for long-term vegetable exposure. The concentrations were calculated using standard curves derived from authentic HPLC-purified standards of α-retinol and retinol.

03

Conditions studied

  • Vitamin A Deficiency
  • Vitamin A Toxicity

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Keywords

  • aging
  • alpha-retinol
  • hypervitaminosis A
  • vitamin A biomarkers
  • serum retinol
04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

US adult cadavers from the the National Disease Research Interchange service age 21 years and older, death from any cause.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Human liver and serum samples were acquired as a consecutive sample through a request to the National Disease Research Interchange service, based on sex and age range targets (5 male and 5 female per age group; age groups: 21-54 ; 55-74; 75 and above).

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
27 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 21-54 y

    Ages 21-54 y

  • 55-74 y

    Ages 55-74 y

  • >75 y

    Age \>75 y

06

What researchers measure

Primary outcomes

  1. Serum retinyl esters, nmol/L

    Concentration of retinyl esters in subjects' serum

    Time frame: Enrollment

  2. Liver vitamin A reserves, µmol/g

    Concentration of vitamin A in subjects' liver samples

    Time frame: Enrollment

Secondary outcomes

  1. Serum retinol, µmol/L

    Concentration of retinol in subjects' serum

    Time frame: Enrollment

  2. Liver alpha-retinyl ester, nmol/g

    Concentration of alpha-retinyl esters in subjects' liver samples

    Time frame: Enrollment

07

Study locations

1 site
  • University of Wisconsin - Madison
    Madison, Wisconsin 53706, United States
08

References and documents

Publications

  • 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. PubMed 30475970 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2012 to primary completion in Jan 2017, 59 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2017
First posted
Oct 9, 2017
StartActual
Feb 1, 2012
Primary completionActual
Jan 31, 2017
CompletionActual
Jan 31, 2017
Last update
Oct 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03305042
Responsible party
Sponsor
First posted
Oct 9, 2017
Start date
Feb 1, 2012
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017
Last update
Oct 17, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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