Vitamin A Deficiency Clinical Trial
Official title:
Vitamin A Liver Reserves and Serum Markers of Vitamin A in US Adults at Time of Death
Verified date | October 2017 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | January 31, 2017 |
Est. primary completion date | January 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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: |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin - Madison | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum retinyl esters, nmol/L | Concentration of retinyl esters in subjects' serum | Enrollment | |
Primary | Liver vitamin A reserves, µmol/g | Concentration of vitamin A in subjects' liver samples | Enrollment | |
Secondary | Serum retinol, µmol/L | Concentration of retinol in subjects' serum | Enrollment | |
Secondary | Liver alpha-retinyl ester, nmol/g | Concentration of alpha-retinyl esters in subjects' liver samples | Enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
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