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
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.
