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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
124
Ferrodunal capsules providing 100 mg elemental oral iron once daily
• 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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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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.
Higher scores indicate better health-related quality of life. Usually ≤1 (can be negative in some tariffs).
Time frame: 12 weeks
Change in serum iron from baseline to weeks 6 and 12.
Time frame: 12 weeks
Change in serum hemoglobin from baseline to weeks 6 and 12.
Time frame: 12 weeks
Change in serum CRP from baseline to weeks 6 and 12.
Time frame: 12 weeks
Medication adherence will be assessed through participant self-report at each follow-up visit.
Time frame: 12 weeks