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Adjunctive Oral Iron Supplementation in Atopic Dermatitis

2026年5月21日更新者：Eglal Adel Mostafa Bassiouny、Cairo University

Adjunctive Oral Iron Supplementation in Atopic Dermatitis: A Randomized Controlled Trial

The present randomized controlled trial aims to evaluate the effect of adjunctive oral iron supplementation on disease severity and quality of life in adolescents with mild to moderate atopic dermatitis. In addition, the study will explore whether baseline iron status modifies treatment response and whether changes in iron biomarkers correlate with improvements in clinical severity scores.

研究概览

地位

尚未招聘

条件

特应性皮炎

干预/治疗

膳食补充剂：Oral iron

研究类型

介入性

注册 (估计的)

124

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Eglal AM Bassiouny, PhD
电话号码：00201061500242
邮箱：eglal.mostafa@pharma.cu.edu.eg

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子

接受健康志愿者

不

描述

Inclusion Criteria:

Adolescents aged 12 to 16 years.
Diagnosis of atopic dermatitis according to Hanifin and Rajka or UK Working Party criteria.
Mild to moderate disease defined as EASI score 1.1-7.0 for mild and 7.1-21.0 for moderate disease, according to the severity classification of Leshem et al. (2015).
Stable standard-of-care topical therapy for at least two weeks prior to enrolment.
Willingness to maintain baseline topical therapy throughout the study period.
Written informed consent from a parent or legal guardian and assent from the participant will be obtained prior to enrolment.

Exclusion Criteria:

Iron-related exclusions
1. Known iron overload disorders (e.g., hereditary hemochromatosis).
2. Ferritin above age- and sex-specific upper reference limits for adolescents (based on local laboratory pediatric reference ranges) in the absence of elevated CRP.
3. Use of oral or intravenous iron supplementation within the previous three months.
  Hematologic exclusions
4. Haemoglobin less than 8 g/dL. Participants excluded on this basis will be referred to the haematology clinic for evaluation and management of severe anaemia, in accordance with the Declaration of Helsinki (Article 37).
5. Known hemoglobinopathies (e.g., thalassemia major, sickle cell disease).
6. Active bleeding or known bleeding disorders. Dermatologic exclusions
7. Presence of other chronic inflammatory skin diseases that may interfere with assessment (e.g., psoriasis, bullous disorders).
8. Active skin infection requiring systemic antibiotic therapy.
9. Use of systemic treatments for atopic dermatitis, including:
  - Systemic corticosteroids
  - Immunosuppressants
  - Biologic therapies within the following washout periods: dupilumab ≥12-16 weeks; cyclosporine ≥4 weeks; methotrexate ≥4-6 weeks; systemic corticosteroids ≥2-4 weeks.
  Systemic exclusions
10. Severe chronic illnesses that may affect study participation or safety, including:
  - Advanced kidney disease
  - Chronic liver disease
11. Any other medical condition that, in the investigator's judgment, may interfere with study participation or outcomes.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
无干预：standard-of-care topical therapy (emollients and steroids) Participants will receive standard-of-care topical therapy (emollients and steroids). Standard topical therapies for atopic dermatitis will be continued and documented.
实验性的：standard-of-care topical therapy (emollients and steroids)+ Oral Iron Participants will receive (Ferrodunal capsules providing 100 mg elemental oral iron once daily) in addition to standard-of-care topical therapy (emollients and steroids). The 100 mg fixed dose falls within the recommended paediatric dosing range of 3-6 mg/kg/day for most adolescents weighing ≥20 kg. Iron supplementation will be discontinued if serum ferritin exceeds 300 ng/mL on two consecutive measurements.	膳食补充剂：Oral iron Ferrodunal capsules providing 100 mg elemental oral iron once daily

参与者组/臂

干预/治疗

无干预：standard-of-care topical therapy (emollients and steroids)

Participants will receive standard-of-care topical therapy (emollients and steroids). Standard topical therapies for atopic dermatitis will be continued and documented.

实验性的：standard-of-care topical therapy (emollients and steroids)+ Oral Iron

Participants will receive (Ferrodunal capsules providing 100 mg elemental oral iron once daily) in addition to standard-of-care topical therapy (emollients and steroids). The 100 mg fixed dose falls within the recommended paediatric dosing range of 3-6 mg/kg/day for most adolescents weighing ≥20 kg. Iron supplementation will be discontinued if serum ferritin exceeds 300 ng/mL on two consecutive measurements.

膳食补充剂：Oral iron

Ferrodunal capsules providing 100 mg elemental oral iron once daily

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
• Change in Eczema Area and Severity Index (EASI) score from baseline to week 12. 大体时间：12 weeks	Higher scores indicate more severe atopic dermatitis, Minimum score is 0 and maximum is 72.	12 weeks

次要结果测量

结果测量	措施说明	大体时间
Change in SCORing Atopic Dermatitis (SCORAD) score from baseline to weeks 6 and 12. 大体时间：12 weeks	Higher scores indicate more severe disease and symptoms. Maximum score is 103 and minimum is zero.	12 weeks
Change in Children's Dermatology Life Quality Index (CDLQI) from baseline to weeks 6 and 12. 大体时间：12 weeks	Higher scores indicate greater impairment in quality of life. Score from 0 to 30.	12 weeks
Change in Patient-Oriented Eczema Measure (POEM) from baselines to weeks 6 and 12. 大体时间：12 weeks	Higher scores indicate worse eczema symptoms. Maximum score is 28 and minimum is 0.	12 weeks
Change in EuroQol Visual Analogue Scale (EQ-VAS) from baseline to weeks 6 and 12. 大体时间：12 weeks	Higher scores indicate better perceived overall health. Score is from 0 to 100.	12 weeks
Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline to weeks 6 and 12. 大体时间：12 weeks	Higher scores indicate more severe itching. Score is from 0 to 10.	12 weeks
Change in serum ferritin from baseline to weeks 6 and 12. 大体时间：12 weeks		12 weeks
Proportion of participants achieving EASI-50, EASI-75, and EASI-90. 大体时间：12 weeks		12 weeks
Adverse events frequency 大体时间：12 weeks		12 weeks
Medication adherence will be assessed through capsule counts at each follow-up visit. 大体时间：12 weeks		12 weeks
Correlation between baseline iron status strata and EASI score. (exploratory outcome) 大体时间：12 weeks		12 weeks
Correlation between change in iron biomarkers and change in EASI score. (exploratory outcome) 大体时间：12 weeks		12 weeks
Change in EQ-5D-Y index score from baseline to weeks 6 and 12. 大体时间：12 weeks	Higher scores indicate better health-related quality of life. Usually ≤1 (can be negative in some tariffs).	12 weeks
Change in serum iron from baseline to weeks 6 and 12. 大体时间：12 weeks		12 weeks
Change in serum hemoglobin from baseline to weeks 6 and 12. 大体时间：12 weeks		12 weeks
Change in serum CRP from baseline to weeks 6 and 12. 大体时间：12 weeks		12 weeks
Medication adherence will be assessed through participant self-report at each follow-up visit. 大体时间：12 weeks		12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cairo University

调查人员

首席研究员：Eglal AM Bassiouny, PhD、Cairo University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年5月17日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月21日

最后验证

2026年5月1日

Adjunctive Oral Iron Supplementation in Atopic Dermatitis