The Impact of Salt Intake on Sodium in the Skin and Inflammatory Skin Disease
NCT07487831 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-03-23
Summary
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
Conditions
- Atopic Dermatitis (Eczema)
- Psoriasis
Interventions
- DRUG
-
Sodium chloride tablets
During the 5-week long sodium tablet intervention period, participants will receive five 1 g sodium chloride tablets each morning and four 1 g sodium chloride tablets each evening. Each sodium chloride tablet will contain 0.394 g or 17 mmol of sodium
- OTHER
-
Placebo Tablets
During the 5-week long placebo period, participants will receive five placebo tablets each morning and four placebo tablets each evening.
Sponsors & Collaborators
-
LEO Foundation
collaborator UNKNOWN -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Katrina Abuabara, MD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-16
- Primary Completion
- 2028-03-17
- Completion
- 2028-03-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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