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
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.
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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
Browse Vitamin A Deficiency studies →5 of the 16 studies in Vitamin A Deficiency with a site in United States are open now. Recruiting first, the newest first:
Opus Genetics, Inc · Sites in United States
Ages 18+
University of Minnesota · Sites in United States
Ages 18–60 · Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 18+
MD Stem Cells · Sites in United States, Austria, United Arab Emirates
Ages 18+
University of Mississippi Medical Center · Sites in United States
Ages 18–45
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 →
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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16 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 27 is below the median of 258 across 17 observational studies indexed under Vitamin A Deficiency.
Median enrollment 86 across the 12 interventional studies, 48 across the 4 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
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3 of 16 have an industry lead sponsor. The 10 most frequent:
University of Wisconsin, Madison is the lead sponsor of 1,189 studies on the registry; 182 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
University of Wisconsin, Madison has 3 studies filed under Vitamin A Deficiency — fewer than ten, so there is no comparison to draw.
4 of the studies in Vitamin A Deficiency with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07140783Phase 3Opus Genetics, IncOPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity | 2027-08 |
| NCT07736768University of Mississippi Medical CenterVitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants | 2027-07-30 |
| NCT03011541MD Stem CellsStem Cell Ophthalmology Treatment Study II | 2027-07-31 |
| NCT06450925Children's Hospital Medical Center, CincinnatiVitamin A Supplementation in Allogeneic Stem Cell Transplantation. | 2027-08 |
Add all 4 to your calendar (.ics) → With an account.
Among the 16 studies in Vitamin A Deficiency with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
US adult cadavers from the the National Disease Research Interchange service age 21 years and older, death from any cause.
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Exclusion Criteria:
Ages 21-54 y
Ages 55-74 y
Age \>75 y
Serum retinyl esters, nmol/L
Concentration of retinyl esters in subjects' serum
Time frame: Enrollment
Liver vitamin A reserves, µmol/g
Concentration of vitamin A in subjects' liver samples
Time frame: Enrollment
Serum retinol, µmol/L
Concentration of retinol in subjects' serum
Time frame: Enrollment
Liver alpha-retinyl ester, nmol/g
Concentration of alpha-retinyl esters in subjects' liver samples
Time frame: Enrollment
Plan to share: No
Ran from Feb 2012 to primary completion in Jan 2017, 59 months.
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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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University of Wisconsin, Madison →