Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07447063

The Impact of Dietary Salt on the Severity of Eczema

The goal of this clinical trial is to evaluate the feasibility of low-sodium diet to improve eczema severity. The main questions it aims to answer are:

* Does a low-sodium diet improve eczema severity? * How does a low-sodium diet impact skin sodium concentration? * Is skin sodium concentration associated with eczema severity?

Researchers will ask all participant to follow a low-sodium diet, then 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 24-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 * Complete up to 4 virtual check-in visits * Visit the clinic 4 times to answer questionnaires, provide bio samples, complete dietary recalls, and undergo non-contrast sodium MRI

Not Yet Recruiting

Trial opening soon.

Get Notified

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

Loading trial locations.

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 eczema severity.

The study will recruit 40 individuals (10 healthy participants, 30 with moderate-severe atopic dermatitis) and follow them to identify factors associated with skin sodium storage.

All participants will be counseled on how to follow a low-sodium diet for 24 weeks. After 12 weeks on the diet alone, they will be asked to add daily 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 13-17, no tablets for a washout period during weeks 18-19, then placebo tablets for weeks 20-24. The other group will receive placebo tablets for weeks 13-17, no tablets for a washout period during weeks 18-19, then sodium tablets for weeks 20-24. Sodium consumption will be evaluated using dietary recall questionnaires and urine biomarkers, skin sodium concentration will be measured using a non-invasive sodium MRI technique, and eczema activity and severity will be measured using multiple patient-reported outcomes and clinician scores.

To test the hypothesis that the low-sodium DASH diet improves eczema severity, we will compare eczema severity before and after the 12-week low-sodium dietary intervention. As secondary objectives, we will also test whether increases in dietary sodium administered as sodium chloride tablets during the second 12-week study period are associated with increases in skin sodium concentration corresponding to eczema severity, and whether there are protein biomarkers in the skin or blood that are associated with changes in dietary sodium, skin sodium concentration, and/or eczema severity.

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. Eczema severity

    Time frame: 6 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.

Secondary outcomes

  1. Skin sodium concentration

    Time frame: 6 months

    Skin sodium concentration (mmol/L) will be measured via non-contrast sodium MRI; change in the value after the interventions and mean values between groups will be compared

  2. Protein biomarkers

    Time frame: 6 months

    Fold-changes in protein biomarkers extracted from skin tape strips and blood will be compared; change in the value after the interventions and mean values between groups will be compared

  3. Atopic dermatitis severity measured by POEM score

    Time frame: 6 months

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

  4. Atopic dermatitis control measured by mean RECAP score

    Time frame: 6 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 interventions and mean scores between groups will be compared.

  5. Participant-reported itch score

    Time frame: 6 months

    Atopic dermatitis-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 and mean scores between groups will be compared.

  6. Skin-related quality of life score

    Time frame: 6 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 and mean scores between groups will be compared.

Study contacts

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

Alicia Hamblin, BS

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

  • United States Department of Defense

Registry information

Acronym: iDOSE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 3, 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.

Published trials that share one or more normalized conditions with this study.