Dietary Salt for Eczema

(iDOSE Trial)

Not yet recruiting at 1 trial location

Overseen By Alicia Hamblin, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Diuretics, SGLT2 inhibitors, Antibiotics

Disqualifiers: Cardiac event, Liver/kidney impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Katrina Abuabara, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing and able to undergo non-contrast MRI

I only use topical medications on my head, neck, hands, or feet.

I am at least 18 years old.

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

I have taken antibiotics or immune system medications in the past month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants follow a low-sodium diet for 12 weeks to assess its impact on eczema severity

12 weeks

2 visits (in-person), 2 visits (virtual)

Crossover Treatment

Participants receive sodium tablets or placebo for 5 weeks, followed by a 2-week washout, then switch treatments for another 5 weeks

12 weeks

2 visits (in-person), 2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low-sodium diet
• Placebo Tablets
• Sodium chloride tablets

How Is the Trial Designed?

Group I: Sodium tablets first Experimental Treatment 2 Interventions

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.

Group II: Placebo tablets first Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+