Adjunctive Oral Iron Supplementation in Atopic Dermatitis

Sponsor
Cairo University
Study ID
NCT07613190
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral iron — DIETARY_SUPPLEMENT
    Ferrodunal capsules providing 100 mg elemental oral iron once daily

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
May 31, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Central Contacts

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