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

Phase 4Not Yet RecruitingNCT07487831

University of California, San Francisco50 enrolled

Overview

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

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 a low-sodium diet can improve inflammatory skin disease severity. This study is meant to generate pilot data to complement the iDOSE trial (NCT07447063). The study will recruit 50 individuals (10 participants with atopic dermatitis, 10 with psoriasis, and up to 30 'healthy' individuals without skin disease) and measure skin sodium concentration using a non-invasive sodium MRI technique. Healthy individuals will only undergo sodium scans at Visit 1. Participants with atopic dermatitis and psoriasis will be counseled on how to follow the DASH low-sodium diet and asked to maintain the diet for the duration of the 13-week study. After a 1-week wash-in period on the diet alone, they will be asked to add daily sodium chloride tablets in a self-controlled cross-over design. Participants will be randomized in equal groups to either start with sodium tables or placebo tablets. One group will receive sodium tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then placebo tablets for weeks 9-13. The other group will receive placebo tablets for weeks 2-6, no tablets for a washout period during weeks 6-8 then sodium tablets for weeks 8-13. Sodium consumption will be evaluated using dietary recall questionnaires and urine biomarkers and eczema and psoriasis activity and severity will be measured using validated severity scores and patient-reported outcomes.

Study Type

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

Fidelity of low-salt diet

Fidelity of the low-salt diet and sodium tab intervention adherence will be assessed based on sodium levels from food recall questionnaires and 24-hour urine sodium samples.

Time frame: 4 months

Feasibility measured by recruitment rates and exclusion and non-participation reasons

To assess feasibility, we will calculate recruitment rates and reasons for exclusion and non-participation will be summarized using descriptive statistics.

Time frame: 4 months

Retention rates

Retention rates will be calculated as the proportion of visits completed. We will compare retention rates by study arm and participant characteristics.

Time frame: 4 months

Secondary Outcomes

Eczema severity

Eczema severity will be measured by the Eczema Area Severity Index (EASI). The score range is 0-72 and higher scores indicate more severe eczema. Change in the score after the intervention periods will be compared.

Time frame: 4 months

Atopic dermatitis severity measured by POEM score

Atopic dermatitis severity will be tracked via assessments at clinic visits using the Patient Oriented Eczema Measure (POEM). The POEM score ranges from 0-28 and higher scores indicate more severe atopic dermatitis; change in the score after the intervention peroids will be compared.

Time frame: 4 months

Atopic dermatitis control measured by mean RECAP score

Atopic dermatitis control will be measured at participant visits using the Recap of Atopic Eczema (RECAP) measure of long term control. Scores range from 0-28, and higher scores indicate more severe atopic dermatitis. Change in the score after the intervention periods will be compared.

Time frame: 4 months

Psoriasis severity

Psoriasis severity will be measured by the Psoriasis Area and Severity Index (PASI). The score range is 0-72 and higher scores indicate more severe psoriasis. Change in the score after the intervention periods will be compared.

Time frame: 4 months

Participant-reported psoriasis severity measured by PSI score

Psoriasis severity will be tracked via assessments at clinic visits using the Psoriasis Symptom Inventory (PSI). The PSI score ranges from 0-32 and higher scores indicate more severe psoriasis. Change in the score after the interventions will be compared.

Time frame: 4 months

Presence of psoriatic arthritis

Potential underlying psoriatic arthritis will be assessed using the Psoriasis Epidemiology Screening Tool (PEST). The PEST score ranges from 0-5 and a score of 3 or higher indicates potential psoriatic arthritis; presence of psoriatic arthritis after the interventions and between groups will be compared.

Time frame: 4 months

Participant-reported itch score

Atopic dermatitis or psoriasis-associated itch will be assessed at clinic visits using the numerical rating score for itch (NRS 11). The range for the NRS is 0-10, and higher scores indicate more severe itch / worse disease. Change in the score after the interventions will be compared.

Time frame: 4 months

Skin-related quality of life score

Skin-related quality of life will be measured at participant visits using the Dermatology Life Quality Index (DLQI). Scores range from 0-30, and higher scores indicate worse outcomes. Change in the score after the interventions will be compared.

Time frame: 4 months

Clinician-reported overall severity of eczema and psoriasis

Clinician-reported overall severity of eczema and psoriasis will be assessed using the Investigator's Global Assessment (IGA). Scores range from 0-4, and higher scores indicate worse outcomes. Change in the score after the intervention periods will be compared.

Time frame: 4 months

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts