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

NCT03305042 | Completed

• 1 other identifier: 2015-1482
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin A Deficiency; Vitamin A Toxicity

Keywords

aging; alpha-retinol; hypervitaminosis A; vitamin A biomarkers; serum retinol

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Serum retinol, µmol/L

  Enrollment

• Liver alpha-retinyl ester, nmol/g

  Enrollment

Study Arms (3)

21-54 y

Ages 21-54 y

55-74 y

Ages 55-74 y

>75 y

Age \>75 y

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

• 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.

  PMID: 30475970 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and liver samples

MeSH Terms

Conditions

Vitamin A Deficiency; Hypervitaminosis A

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 9, 2017
• Study Start: February 1, 2012
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: October 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)