The Impact of Salt Intake on Sodium in the Skin and Inflammatory Skin Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Feasibility measured by recruitment rates and exclusion and non-participation reasons
研究概览
简要总结
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:
- Is there an association between skin sodium concentration and atopic dermatitis and psoriasis severity?
- 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
详细描述
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 inflammatory skin disease severity. This study is meant to generate pilot data to complement the iDOSE trial (NCT07447063). The study will recruit 50 individuals (10 participants with atopic dermatitis, 10 with psoriasis, and up to 30 'healthy' individuals without skin disease) and measure skin sodium concentration using a non-invasive sodium MRI technique. Healthy individuals will only undergo sodium scans at Visit 1. Participants with atopic dermatitis and psoriasis will be counseled on how to follow the DASH low-sodium diet and asked to maintain the diet for the duration of the 13-week study. 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. One group will receive sodium tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then placebo tablets for weeks 9-13. The other group will receive placebo tablets for weeks 2-6, no tablets for a washout period during weeks 6-8 then sodium tablets for weeks 8-13. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Clinical research coordinators will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants ages 18 years
- •Willing and able to undergo non-contrast MRI.
排除标准
- •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.)
研究组 & 干预措施
Sodium tablets first
Participants will be randomized to receive sodium tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then placebo tablets for weeks 9-13.
干预措施: Sodium chloride tablets (Drug)
Placebo tablets first
Participants will be randomized to receive placebo tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then sodium tablets for weeks 9-13.
干预措施: Sodium chloride tablets (Drug)
Sodium tablets first
Participants will be randomized to receive sodium tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then placebo tablets for weeks 9-13.
干预措施: Placebo Tablets (Other)
Placebo tablets first
Participants will be randomized to receive placebo tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then sodium tablets for weeks 9-13.
干预措施: Placebo Tablets (Other)
结局指标
主要结局
Feasibility measured by recruitment rates and exclusion and non-participation reasons
时间窗: 4 months
To assess feasibility, recruitment rates will be calculated and reasons for exclusion and non-participation will be summarized using descriptive statistics.
Retention rates
时间窗: 4 months
Retention rates will be calculated as the proportion of visits completed and will be compared by study arm and participant characteristics.
Fidelity of low-salt diet
时间窗: 4 months
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.
次要结局
- Eczema severity(4 months)
- Atopic dermatitis severity measured by POEM score(4 months)
- Atopic dermatitis control measured by mean RECAP score(4 months)
- Psoriasis severity(4 months)
- Participant-reported psoriasis severity measured by PSI score(4 months)
- Presence of psoriatic arthritis(4 months)
- Participant-reported itch score(4 months)
- Skin-related quality of life score(4 months)
- Clinician-reported overall severity of eczema and psoriasis(4 months)