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NCT Number: NCT07487831

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Francisco VA Medical Center, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Primary outcomes

  1. Fidelity of low-salt diet

    Time frame: 4 months

    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.

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

    Time frame: 4 months

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

  3. Retention rates

    Time frame: 4 months

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

Secondary outcomes

  1. Eczema severity

    Time frame: 4 months

    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.

  2. Atopic dermatitis severity measured by POEM score

    Time frame: 4 months

    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.

  3. Atopic dermatitis control measured by mean RECAP score

    Time frame: 4 months

    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.

  4. Psoriasis severity

    Time frame: 4 months

    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.

  5. Participant-reported psoriasis severity measured by PSI score

    Time frame: 4 months

    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.

  6. Presence of psoriatic arthritis

    Time frame: 4 months

    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.

  7. Participant-reported itch score

    Time frame: 4 months

    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.

  8. Skin-related quality of life score

    Time frame: 4 months

    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.

  9. Clinician-reported overall severity of eczema and psoriasis

    Time frame: 4 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alicia Hamblin

CONTACT

[email protected]

925-549-7889

Katrina Abuabara, MD

CONTACT

[email protected]

415-514-9769

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • LEO Foundation

Registry information

Acronym: SIS-ISD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 23, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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