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Trial record 38 of 156 for:    NIDCD

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

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ClinicalTrials.gov Identifier: NCT03305042
Recruitment Status : Completed
First Posted : October 9, 2017
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease
Vitamin A Deficiency Vitamin A Toxicity

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Vitamin A Liver Reserves and Serum Markers of Vitamin A in US Adults at Time of Death
Actual Study Start Date : February 1, 2012
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Group/Cohort
21-54 y
Ages 21-54 y
55-74 y
Ages 55-74 y
>75 y
Age >75 y



Primary Outcome Measures :
  1. Serum retinyl esters, nmol/L [ Time Frame: Enrollment ]
    Concentration of retinyl esters in subjects' serum

  2. Liver vitamin A reserves, µmol/g [ Time Frame: Enrollment ]
    Concentration of vitamin A in subjects' liver samples


Secondary Outcome Measures :
  1. Serum retinol, µmol/L [ Time Frame: Enrollment ]
    Concentration of retinol in subjects' serum

  2. Liver alpha-retinyl ester, nmol/g [ Time Frame: Enrollment ]
    Concentration of alpha-retinyl esters in subjects' liver samples


Biospecimen Retention:   Samples Without DNA
Serum and liver samples


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305042


Locations
United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Deafness and Other Communication Disorders (NIDCD)

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03305042     History of Changes
Other Study ID Numbers: 2015-1482
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:
aging
alpha-retinol
hypervitaminosis A
vitamin A biomarkers
serum retinol

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents