Adjunctive Oral Iron Supplementation in Atopic Dermatitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: Oral iron

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eglal AM Bassiouny, PhD; Phone Number: 00201061500242; Email: eglal.mostafa@pharma.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adolescents aged 12 to 16 years.
2. Diagnosis of atopic dermatitis according to Hanifin and Rajka or UK Working Party criteria.
3. 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).
4. Stable standard-of-care topical therapy for at least two weeks prior to enrolment.
5. Willingness to maintain baseline topical therapy throughout the study period.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Dietary supplement: Oral iron; Ferrodunal capsules providing 100 mg elemental oral iron once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Change in Eczema Area and Severity Index (EASI) score from baseline to week 12.	Higher scores indicate more severe atopic dermatitis, Minimum score is 0 and maximum is 72.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SCORing Atopic Dermatitis (SCORAD) score from baseline to weeks 6 and 12.	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.	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.	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.	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.	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.		12 weeks
Proportion of participants achieving EASI-50, EASI-75, and EASI-90.		12 weeks
Adverse events frequency		12 weeks
Medication adherence will be assessed through capsule counts at each follow-up visit.		12 weeks
Correlation between baseline iron status strata and EASI score. (exploratory outcome)		12 weeks
Correlation between change in iron biomarkers and change in EASI score. (exploratory outcome)		12 weeks
Change in EQ-5D-Y index score from baseline to weeks 6 and 12.	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.		12 weeks
Change in serum hemoglobin from baseline to weeks 6 and 12.		12 weeks
Change in serum CRP from baseline to weeks 6 and 12.		12 weeks
Medication adherence will be assessed through participant self-report at each follow-up visit.		12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Eglal AM Bassiouny, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Randomized controlled trial; Iron supplementation; Atopic dermatitis; Iron deficiency; CDLQI; EASI; SCOٌِRAD; EQ-5D-Y
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Metabolic Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Iron Metabolism Disorders; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Iron Deficiencies; Dermatitis, Atopic; Inorganic Chemicals; Elements; Metals; Metals, Heavy; Transition Elements; Iron
• Other Study ID Numbers: CL4181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No