The Impact of Dietary Salt on the Severity of Eczema
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About 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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants ages 18 years
Willing and able to undergo non-contrast MRI.
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Sodium chloride tablets
DrugDuring 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
Other interventionDuring the 5-week long placebo period, participants will receive five placebo tablets each morning and four placebo tablets each evening
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Sodium tablets firstExperimental treatment 2 interventions
Group B: Placebo tablets firstExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov