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RECRUITING Phase 4 ClinicalTrials.gov

The Impact of Salt Intake on Sodium in the Skin and Inflammatory Skin Disease

Sponsor: University of California, San Francisco • ClinicalTrials.gov ID: NCT07487831

Registry updated: 2026-09-09
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Description

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

Interventions

  • Sodium chloride tablets (Drug)
    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
  • Placebo Tablets (Other)
    During the 5-week long placebo period, participants will receive five placebo tablets each morning and four placebo tablets each evening.

Eligibility criteria

Inclusion Criteria: * Participants ages 18 years * Willing and able to undergo non-contrast MRI. Exclusion Criteria: * 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) * Antibiotic or immunomodulatory medications within the last month * Contraindications to sodium tablets (Topical medications used exclusively on the head/neck or hands/feet (e.g., antifungal nail treatment, antidandruff shampoo, acne cleansers) are acceptable. Topical and systemic eczema treatments are acceptable if the participant has been on a stable dose for at least 2 months and still meets the severity entry criteria. Patients on dupilumab will not be excluded if they have been on dupilumab for at least two months and still meet the disease severity inclusion criteria.)

Conditions

Atopic Dermatitis (Eczema) Psoriasis

Locations

  • UCSF Mt Zion Campus — San Francisco, California, United States
  • San Francisco VA Medical Center — San Francisco, California, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record