RightFit
RecruitingPhase 4

The Impact of Salt Intake on Sodium in the Skin and Inflammatory Skin Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 weeks
  • Procedures mentioned: MRI scans, Questionnaires, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: * Follow a low-salt diet for the duration of the 13-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 * Visit the clinic up to 4 times to answer questionnaires, provide bio samples, complete dietary recalls, and undergo non-contrast sodium MRI"
  • "After a 1-week wash-in period on the diet alone, they will be asked to add daily sodium chloride tablets in a self-controlled cross-over design."
  • "Participants will be randomized in equal groups to either start with sodium tables or placebo tablets."
  • "Sodium consumption will be evaluated using dietary recall questionnaires and urine biomarkers and eczema and psoriasis activity and severity will be measured using validated severity scores and patient-reported outcomes."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 13-week study tests whether changing salt intake affects salt levels in the skin and the severity of eczema and psoriasis, two skin diseases. Participants follow a low-salt diet and take salt tablets and look-alike tablets with no drug at different times. The study lists age 18 for entry and requires people to be able to have an MRI scan.

The goal of this clinical trial is to demonstrate the feasibility of a trial that examines the impact of changes in dietary sodium intake on skin sodium levels, atopic dermatitis, and psoriasis. In addition, it aims to generate preliminary data to begin to answer the following questions: 1. Is there an association between skin sodium concentration and atopic dermatitis and psoriasis severity? 2. Are changes in dietary sodium are associated with changes in skin sodium concentration and atopic dermatitis and psoriasis severity? Researchers will 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 13-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 * Visit the clinic up to 4 times to answer questionnaires, provide bio samples, complete dietary recalls, and undergo non-contrast sodium MRI

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18, as listed in the study.
  • Willing and able to have an MRI scan without contrast dye.

Who can't join

  • Cannot safely have an MRI, such as because of certain implants, a pacemaker, an IUD, or fear of tight spaces.
  • Had a heart-related event in the past 6 months.
  • Have reduced liver or kidney function, including a kidney filtering rate below 60 mL/min.
  • Take medicines that change how much salt leaves the body, such as water pills or SGLT2 inhibitors.
  • Used antibiotics or medicines that change the immune system in the past month. Some eczema treatments are allowed, as noted below.
  • Cannot safely take salt tablets.
  • Some skin treatments are allowed: those used only on the head, neck, hands, or feet. Eczema treatments, including dupilumab, are allowed if the dose has been stable for at least 2 months and the person still meets the study’s disease severity rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participants ages 18 years * Willing and able to undergo non-contrast MRI. 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 * Impaired function of the liver or kidney (glomerular filtration rate \<60 mL/min) * Medications that influence sodium excretion (e.g., diuretics or SGLT2 inhibitors) * Antibiotic or immunomodulatory medications within the last month * Contraindications to sodium tablets (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.)

Study sites (2)

CA