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The goal of this observational study is to understand factors associated with skin sodium storage in healthy adults and people with atopic dermatitis ages 50 and above. The study is designed to test whether diet and skin barrier function are associated with skin sodium concentration and whether skin sodium concentration is linked to atopic dermatitis and immune profiles over time. Participants will be asked to complete questionnaires, provide bio samples, and undergo non-contrast sodium MRI at 2-3 time points over 3-24 months.
The central hypothesis of this proposal is that excess dietary sodium (consumed primarily as salt) is concentrated in the skin as a physiologic response to poor barrier function, and that high levels of skin sodium worsen atopic dermatitis. The study will recruit 90 individuals (30 healthy participants, 30 with mild atopic dermatitis and 30 with severe atopic dermatitis) and follow them to identify factors associated with skin sodium storage. Diet will be evaluated using food frequency questionnaires and urine biomarkers, skin sodium concentration will be measured using a non-invasive sodium MRI technique, and atopic dermatitis activity and severity will be measured using multiple patient-reported outcomes and clinician scores. Participants without atopic dermatitis will be asked to visit the research site 4 times over 3 months. Participants with atopic dermatitis will be additionally asked to complete monthly severity scores for up to 24 months total and to visit the research site an additional 2 times when their disease severity changes. The first specific aim will evaluate the association between dietary sodium intake and skin barrier function on skin sodium concentration. The primary analysis will use regression models to determine the association between dietary sodium intake and skin sodium concentration across 2-3 time points. The association with skin barrier function will also be evaluated. The second specific aim will evaluate the extent to which skin sodium is associated with atopic dermatitis severity and persistence. The analysis will use regression models to determine the association between skin sodium and atopic dermatitis prevalence and severity. It will also examine immune profiles associated with skin sodium.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
Yes
San Francisco VA Medical Center
San Francisco, California, United States
UCSF Mt Zion Campus
San Francisco, California, United States
Start Date
May 12, 2025
Primary Completion Date
August 30, 2028
Completion Date
August 30, 2028
Last Updated
May 31, 2025
90
ESTIMATED participants
Lead Sponsor
University of California, San Francisco
Collaborators
NCT07262983
NCT06389136
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06342713