Authors
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Saglik Bilimleri Universitesi -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized byrecurrent pruritic skin lesions during childhood and has a significant negative impact onquality of life. Since its etiology is often unknown, treatment approaches generallyfocus on symptom control. However, pharmacological treatments do not always provide anadequate response, increasing the importance of complementary dietary approaches. Inrecent years, the Mediterranean diet, known for its anti‐inflammatory properties, and thelow‐histamine diet, which restricts foods with a high histamine content, have emerged aspromising options for the management of CSU symptoms. However, no controlled study hasdirectly compared these two dietary approaches in the pediatric population.This study is planned as a three‐arm randomized controlled clinical trial aiming tocompare the effects of Mediterranean and low‐histamine dietary interventions on diseaseactivity, disease control, and quality of life in children aged 12‐18 years diagnosedwith chronic spontaneous urticaria. The intervention period will last four weeks, andassessments will be performed at baseline and at the end of the fourth week. The studywill use the Urticaria Activity Score over 7 days (UAS7), the Urticaria Control Test(UCT), quality of life questionnaires (Children's Dermatology Life Quality Index [CDLQI]and Dermatology Life Quality Index [DLQI]), and the Mediterranean Diet Quality Index forChildren and Adolescents (KIDMED). Dietary patterns will be assessed using a FoodFrequency Questionnaire (FFQ) at baseline and monitored during the intervention periodthrough weekly 24‐hour dietary recalls and Dietary Adherence Follow‐up Forms. Inaddition, routinely obtained clinical laboratory parameters, including C‐reactive protein(CRP), erythrocyte sedimentation rate (ESR), total immunoglobulin E (total IgE), thyroidfunction tests (TSH and fT4), thyroid autoantibodies (anti‐TPO and anti‐Tg), completeblood count, and 25‐hydroxyvitamin D [25(OH)D] levels, will be evaluated at baseline.This study is expected to fill an important gap in the current literature bydemonstrating the effectiveness of dietary approaches in pediatric chronic spontaneousurticaria and to contribute to clinical practice.
Epistemonikos ID: 85cda87b446067cc68598e0a22b072560e995957
First added on: Aug 14, 2026