The Impact of Salt Intake on Sodium in the Skin and Inflammatory Skin Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
The goal of this clinical trial is to demonstrate the feasibility of a trial that examines the impact of changes in dietary sodium intake on skin sodium levels, atopic dermatitis, and psoriasis. In addition, it aims to generate preliminary data to begin to answer the following questions:
1. Is there an association between skin sodium concentration and atopic dermatitis and psoriasis severity? 2. Are changes in dietary sodium are associated with changes in skin sodium concentration and atopic dermatitis and psoriasis severity?
Researchers will compare sodium tablets to a placebo (a look-alike substance that contains no drug) to specifically examine the impact of altering sodium intake.
Participants will:
* Follow a low-salt diet for the duration of the 13-week study * Take sodium chloride tablets every day for 5 weeks followed by a placebo every day for 5 weeks after a 2-week washout period, or vice versa * Visit the clinic up to 4 times to answer questionnaires, provide bio samples, complete dietary recalls, and undergo non-contrast sodium MRI
Eligibility criteria
Qualifiers
Participants ages 18 years
Willing and able to undergo non-contrast MRI.
Disqualifiers
Contraindications to MRI (such as cardiac pacemakers, claustrophobia, non-compatible intracranial vascular clips, IUDs, or other implants)
A cardiac event in the past 6 months
Impaired function of the liver or kidney (glomerular filtration rate <60 mL/min)
Medications that influence sodium excretion (e.g., diuretics or SGLT2 inhibitors)
Trial design
Treatments tested in this trial
- Sodium chloride tablets
- Placebo Tablets
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
LEO Foundation
Collaborator
Source ClinicalTrials.gov