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Not yet recruiting NCT07613190

Adjunctive Oral Iron Supplementation in Atopic Dermatitis

No phase Interventional Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral iron.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: 12 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Dietary supplement Oral iron
    Ferrodunal capsules providing 100 mg elemental oral iron once daily

Primary outcome measures

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

Eligibility criteria

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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07613190 · CL4181

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗