Adjunctive Oral Iron Supplementation in Atopic Dermatitis

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Oral iron
  Ferrodunal capsules providing 100 mg elemental oral iron once daily

Первичные конечные точки

• • Change in Eczema Area and Severity Index (EASI) score from baseline to week 12. [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

• Change in SCORing Atopic Dermatitis (SCORAD) score from baseline to weeks 6 and 12. [Срок оценки: 12 weeks]
• Change in Children's Dermatology Life Quality Index (CDLQI) from baseline to weeks 6 and 12. [Срок оценки: 12 weeks]
• Change in Patient-Oriented Eczema Measure (POEM) from baselines to weeks 6 and 12. [Срок оценки: 12 weeks]
• Change in EuroQol Visual Analogue Scale (EQ-VAS) from baseline to weeks 6 and 12. [Срок оценки: 12 weeks]
• Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline to weeks 6 and 12. [Срок оценки: 12 weeks]
• Change in serum ferritin from baseline to weeks 6 and 12. [Срок оценки: 12 weeks]
• Proportion of participants achieving EASI-50, EASI-75, and EASI-90. [Срок оценки: 12 weeks]
• Adverse events frequency [Срок оценки: 12 weeks]
• Medication adherence will be assessed through capsule counts at each follow-up visit. [Срок оценки: 12 weeks]
• Correlation between baseline iron status strata and EASI score. (exploratory outcome) [Срок оценки: 12 weeks]
• Correlation between change in iron biomarkers and change in EASI score. (exploratory outcome) [Срок оценки: 12 weeks]
• Change in EQ-5D-Y index score from baseline to weeks 6 and 12. [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07613190 · CL4181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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