A Phase 4 interventional study of Sodium chloride tablets and Placebo Tablets in Eczema and Atopic Dermatitis, sponsored by University of California, San Francisco. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Prevention
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:
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:
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.
503 studies on the registry are indexed under Eczema; 89 are open to participants now.
This study's planned enrollment of 40 is below the median of 91 across 401 interventional studies indexed under Eczema.
Browse Eczema studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
(Topical medications used exclusively on the head/neck or hands/feet (e.g., antifungal nail treatment, antidandruff shampoo, acne cleansers) are acceptable. Topical and systemic eczema treatments are acceptable if the participant has been on a stable dose for at least 2 months and still meets the severity entry criteria. Patients on dupilumab will not be excluded if they have been on dupilumab for at least two months and still meet the disease severity inclusion criteria.)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
During the 5-week long placebo period, participants will receive five placebo tablets each morning and four placebo tablets each evening
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.
Time frame: 6 months
Skin sodium concentration
Skin sodium concentration (mmol/L) will be measured via non-contrast sodium MRI; change in the value after the interventions and mean values between groups will be compared
Time frame: 6 months
Protein biomarkers
Fold-changes in protein biomarkers extracted from skin tape strips and blood will be compared; change in the value after the interventions and mean values between groups will be compared
Time frame: 6 months
Atopic dermatitis severity measured by POEM score
Atopic dermatitis severity will be tracked via assessments at clinic visits and via virtual monthly assessments using the Patient Oriented Eczema Measure (POEM). The POEM score ranges from 0-28 and higher scores indicate more severe atopic dematitis; change in the score after the interventions and mean scores between groups will be compared.
Time frame: 6 months
Atopic dermatitis control measured by mean RECAP score
Atopic dermatitis control will be measured at participant visits using the Recap of Atopic Eczema (RECAP) measure of long term control. Scores range from 0-28, and higher scores indicate more severe atopic dermatitis; change in the score after the interventions and mean scores between groups will be compared.
Time frame: 6 months
Participant-reported itch score
Atopic dermatitis-associated itch will be assessed at clinic visits using the numerical rating score for itch (NRS 11). The range for the NRS is 0-10, and higher scores indicate more severe itch / worse disease; change in the score after the interventions and mean scores between groups will be compared.
Time frame: 6 months
Skin-related quality of life score
Skin-related quality of life will be measured at participant visits using the Dermatology Life Quality Index (DLQI). Scores range from 0-30, and higher scores indicate worse outcomes; change in the score after the interventions and mean scores between groups will be compared.
Time frame: 6 months
Plan to share: Yes — All IPD that underlie the results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
No publications or documents are linked to this record.
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Studies of the drug tested here: Sodium Chloride
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