40 Participants NeededMy employer runs this trial

Dietary Salt for Eczema

(iDOSE Trial)

Recruiting at 1 trial location
KA
AH
Overseen ByAlicia Hamblin, BS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a low-sodium diet can reduce eczema severity. Researchers aim to determine if reducing salt intake improves eczema and affects skin sodium levels. Participants will follow a low-salt diet and alternate between taking sodium chloride tablets (salt tablets) and placebo tablets. Ideal candidates are those managing eczema who are willing to follow a low-salt diet and undergo non-contrast MRI scans. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot take medications that affect sodium excretion or certain antibiotics and immunomodulatory drugs. If you're using topical or systemic eczema treatments, you can continue them if you've been on a stable dose for at least 2 months.

What is the safety track record for these treatments?

Research has shown that a low-sodium diet might help manage eczema, also known as atopic dermatitis. Studies have found that reducing salt intake is linked to fewer eczema flare-ups, suggesting that a low-sodium diet could be a safe option for people with eczema.

Additionally, there is no strong evidence of major risks from reducing salt intake. Research suggests it's a simple and affordable way to help, with few side effects reported. Most people find a low-sodium diet easy to follow.

In this study, participants will also take sodium tablets and placebo tablets. As this is a Phase 4 trial, earlier stages have typically tested these treatments for safety, demonstrating they are generally safe. Overall, the treatments in this trial are expected to be safe for most participants.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the low-sodium diet for eczema because it offers a novel approach compared to traditional treatments like topical corticosteroids and moisturizers. Unlike these standard options, which focus on managing inflammation and hydration from the outside, a low-sodium diet targets the condition internally by potentially reducing inflammation throughout the body. This dietary intervention could provide a non-invasive and accessible way to manage eczema, appealing particularly to those seeking lifestyle-based solutions.

What evidence suggests that a low-sodium diet could be effective for eczema?

Research has shown that eating less salt might help people with eczema. One study found that individuals with eczema had 30 times more salt in their skin than those without it. Another study demonstrated that reducing salt intake could decrease the chances of eczema flare-ups, which are sudden worsening of symptoms. Participants who followed low-salt guidelines had a 12% lower chance of experiencing eczema. This trial will compare the effects of sodium chloride tablets and placebo tablets on eczema symptoms. These findings suggest that a low-salt diet could be an effective and low-risk way to manage eczema symptoms.14678

Who Is on the Research Team?

KA

Katrina Abuabara, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults (18+) with eczema who can safely have an MRI. Participants must be on stable eczema treatments if using them, and can't join if they have certain implants, recent heart events, severe kidney or liver problems, are taking drugs that affect sodium levels, or can't take sodium tablets.

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.
See 2 more

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.
See 3 more

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

Trial Overview

The study tests whether a low-salt diet and changes in salt intake (using sodium chloride tablets vs placebo) affect eczema severity. All participants follow a low-sodium diet and alternate between real salt tablets and placebo during the 24-week trial.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Sodium tablets firstExperimental Treatment2 Interventions
Group II: Placebo tablets firstExperimental Treatment2 Interventions

Find a Clinic Near You

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38837130/

Sodium Intake and Atopic Dermatitis

These findings suggest that restriction of dietary sodium intake may be a cost-effective and low-risk intervention for AD.

Sodium Intake and Atopic Dermatitis

One small study found that the amount of lesional skin sodium was 30 times greater among patients with AD compared with healthy control ...

Study Finds Association Between Sodium Intake and Risk ...

The study authors observed that changes in daily sodium intake may contribute to eczema flares and a reduction in sodium may be a cost-effective ...

Dietary modifications in atopic dermatitis: patient-reported ...

The best improvement in skin was reported when removing white flour products (37 of 69, 53.6%), gluten (37 of 72, 51.4%) and nightshades (18 of 35, 51.4%).

The Impact of Dietary Salt on the Severity of Eczema (iDOSE)

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 ...

Study: Sodium intake associated with severe eczema

A new study by UC Berkeley School of Public Health found that sodium intake is associated with a higher risk for developing atopic dermatitis, also known as ...

Eating a sodium-rich diet is tied to increased eczema risks

Each additional gram of excreted sodium over the average was associated with 11% increased odds of having eczema, 16% increased odds of having a ...

The Correlation Between Sodium Intake and Eczema

The results indicated a correlation between increased sodium consumption and higher risk for developing eczema.