Health TrialsbyHealthPanel

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

ConditionsAtopic Dermatitis (Eczema)Psoriasis
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 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

    Drug

    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

  • Placebo Tablets

    Other intervention

    During the 5-week long placebo period, participants will receive five placebo tablets each morning and four placebo tablets each evening.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Sodium tablets firstExperimental treatment 2 interventions
Group B: Placebo tablets firstExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Fidelity of low-salt diet

Fidelity of the low-salt diet and sodium tab intervention adherence will be assessed based on sodium levels from food recall questionnaires and 24-hour urine sodium samples.

Time frame
4 months
2

Feasibility measured by recruitment rates and exclusion and non-participation reasons

To assess feasibility, recruitment rates will be calculated and reasons for exclusion and non-participation will be summarized using descriptive statistics.

Time frame
4 months
3

Retention rates

Retention rates will be calculated as the proportion of visits completed and will be compared by study arm and participant characteristics.

Time frame
4 months

Secondary 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. Change in the score after the intervention periods will be compared.

Time frame
4 months
2

Atopic dermatitis severity measured by POEM score

Atopic dermatitis severity will be tracked via assessments at clinic visits using the Patient Oriented Eczema Measure (POEM). The POEM score ranges from 0-28 and higher scores indicate more severe atopic dermatitis; change in the score after the intervention peroids will be compared.

Time frame
4 months
3

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 intervention periods will be compared.

Time frame
4 months
4

Psoriasis severity

Psoriasis severity will be measured by the Psoriasis Area and Severity Index (PASI). The score range is 0-72 and higher scores indicate more severe psoriasis. Change in the score after the intervention periods will be compared.

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

LEO Foundation

Collaborator

Source ClinicalTrials.gov
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