NCT07613190尚未招募不适用
Adjunctive Oral Iron Supplementation in Atopic Dermatitis: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Iron-related exclusions
- •Known iron overload disorders (e.g., hereditary hemochromatosis).
- •Ferritin above age- and sex-specific upper reference limits for adolescents (based on local laboratory pediatric reference ranges) in the absence of elevated CRP.
- •Use of oral or intravenous iron supplementation within the previous three months.
- •Hematologic exclusions
- •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).
- •Known hemoglobinopathies (e.g., thalassemia major, sickle cell disease).
- •Active bleeding or known bleeding disorders. Dermatologic exclusions
- •Presence of other chronic inflammatory skin diseases that may interfere with assessment (e.g., psoriasis, bullous disorders).
- •Active skin infection requiring systemic antibiotic therapy.
- •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
- •Severe chronic illnesses that may affect study participation or safety, including:
- •Advanced kidney disease
- •Chronic liver disease
- •Any other medical condition that, in the investigator's judgment, may interfere with study participation or outcomes.
研究者
Eglal Adel Mostafa Bassiouny
Dr.
Cairo University
相似试验
尚未招募
不适用
Understanding the effect of probiotics consumption in improving the Atopic Dermatitis diseaseCTRI/2024/06/068558Unique Biotech Ltd.60
招募中
不适用
Double-blind, Randomized, Non-inferiority Trial in Atopic Dermatitis: Comparison of Lipikar Balm and Relipid+ Balm in the Treatment of Mild to Moderate Atopic Dermatitis in Children and AdultsEmollientsAtopic DermatitisNCT07358000University Hospital, Caen86
尚未招募
3 期
Comparing ARSENICUM ALBUM IN LM POTENCY to INDIVIDUALIZED HOMOEOPATHIC MEDICINE for the treatment of ECZEMA/ATOPIC DERMATITISCTRI/2024/11/076955Dr NEETHU V48
尚未招募
3 期
A Study to Evaluate the Efficacy and Safety of MG-K10 in Participants Who Have Atopic DermatitisAtopic DermatitisNCT07479615Shanghai Mabgeek Biotech.Co.Ltd498
尚未招募
不适用
Efficacy of Vitamin D Supplementation In Allergic RhinitisCTRI/2025/08/093525Gmers Medical College And Hospital Gotri Vadodara120