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

NCT07487831 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 22-36690
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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:

• 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

Conditions

Atopic Dermatitis (Eczema); Psoriasis

Keywords

sodium; salt; diet

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4 months

Secondary Outcomes (9)

• Eczema severity

  4 months

• Atopic dermatitis severity measured by POEM score

  4 months

• Atopic dermatitis control measured by mean RECAP score

  4 months

• Psoriasis severity

  4 months

• Participant-reported psoriasis severity measured by PSI score

  4 months

Study Arms (2)

Sodium tablets first

EXPERIMENTAL

Participants will be randomized to receive sodium tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then placebo tablets for weeks 9-13.

Drug: Sodium chloride tablets; Other: Placebo Tablets

Placebo tablets first

EXPERIMENTAL

Participants will be randomized to receive placebo tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then sodium tablets for weeks 9-13.

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
• LEO Foundation: collaborator

Study Sites (2)

UCSF Mt Zion Campus

San Francisco, California, 94115, United States

Location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Psoriasis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

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

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: March 17, 2026
• First Posted: March 23, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 17, 2028
• Study Completion (Estimated): March 17, 2028
• Last Updated: March 23, 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)