The Impact of Dietary Salt on the Severity of Eczema

NCT07447063 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: 25-43778HT9425-25-1-0465
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Eczema; Atopic Dermatitis

Keywords

sodium; salt; diet

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• Skin sodium concentration

  6 months

• Protein biomarkers

  6 months

• Atopic dermatitis severity measured by POEM score

  6 months

• Atopic dermatitis control measured by mean RECAP score

  6 months

• Participant-reported itch score

  6 months

Study Arms (2)

Sodium tablets first

EXPERIMENTAL

Participants will be randomized to receive sodium tablets for weeks 13-17, no tablets for a washout period during weeks 18-19, then placebo tablets for weeks 20-24.

Drug: Sodium chloride tablets; Other: Placebo Tablets

Placebo tablets first

EXPERIMENTAL

Participants will be randomized to receive placebo tablets for weeks 13-17, no tablets for a washout period during weeks 18-19, then sodium tablets for weeks 20-24.

Drug: Sodium chloride tablets; Other: Placebo Tablets

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 first; Sodium tablets first

Placebo Tablets OTHER

During the 5-week long placebo period, participants will receive five placebo tablets each morning and four placebo tablets each evening

Placebo tablets first; Sodium tablets first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants ages 18 years
• Willing and able to undergo non-contrast MRI.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• United States Department of Defense: collaborator

Study Sites (2)

San Francisco VA Medical Center

San Francisco, California, 94115, United States

Location

UCSF Mt Zion Campus

San Francisco, California, 94511, United States

Location

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Katrina Abuabara, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Hamblin, BS

CONTACT

925-549-7889; Alicia.Hamblin@ucsf.edu

Katrina Abuabara, MD

CONTACT

415-514-9769; katrina.abuabara@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Clinical research coordinators will be masked.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): March 5, 2028
• Study Completion (Estimated): May 5, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 year and ending 5 years after publication of the results
• Access Criteria: Researchers interested in accessing data from the project must submit a written resource request via email to the Principal Investigator and sign a Data Use Agreement. De-identified data will be shared through a secure server.

Locations

US (2)