Urticaria Chronic
Conditions
Keywords
Chronic Urticaria, Mediterranean Diet, diet, histamine, Adolescent
Brief summary
Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease that can substantially impair quality of life in children and adolescents. Pharmacological treatment may not adequately control symptoms in all patients, increasing interest in dietary interventions. This randomized controlled trial aims to compare the effects of a Mediterranean diet and a low-histamine diet, in addition to standard medical treatment, on disease activity, disease control, and quality of life in pediatric patients aged 12-18 years with chronic spontaneous urticaria. Participants will be allocated to one of three groups: standard treatment alone, standard treatment plus a low-histamine diet, or standard treatment plus a Mediterranean diet. The dietary intervention will last four weeks, with follow-up through eight weeks.
Detailed description
Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by recurrent pruritic skin lesions during childhood and has a significant negative impact on quality of life. Since its etiology is often unknown, treatment approaches generally focus on symptom control. However, pharmacological treatments do not always provide an adequate response, increasing the importance of complementary dietary approaches. In recent years, the Mediterranean diet, known for its anti-inflammatory properties, and the low-histamine diet, which restricts foods with a high histamine content, have emerged as promising options for the management of CSU symptoms. However, no controlled study has directly compared these two dietary approaches in the pediatric population. This study is planned as a three-arm randomized controlled clinical trial aiming to compare the effects of Mediterranean and low-histamine dietary interventions on disease activity, disease control, and quality of life in children aged 12-18 years diagnosed with chronic spontaneous urticaria. The intervention period will last four weeks, and assessments will be performed at baseline and at the end of the fourth week. The study will 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 for Children and Adolescents (KIDMED). Dietary patterns will be assessed using a Food Frequency Questionnaire (FFQ) at baseline and monitored during the intervention period through weekly 24-hour dietary recalls and Dietary Adherence Follow-up Forms. In addition, routinely obtained clinical laboratory parameters, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), total immunoglobulin E (total IgE), thyroid function tests (TSH and fT4), thyroid autoantibodies (anti-TPO and anti-Tg), complete blood 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 by demonstrating the effectiveness of dietary approaches in pediatric chronic spontaneous urticaria and to contribute to clinical practice.
Interventions
OTHERLow-Histamine Diet
Participants assigned to this intervention will receive a low-histamine diet in addition to standard medical treatment for 4 weeks.
OTHERMediterranean Diet
Participants assigned to this intervention will receive a Mediterranean diet in addition to standard medical treatment for 4 weeks.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: standard medical treatment alone, standard medical treatment plus a low-histamine diet, or standard medical treatment plus a Mediterranean diet.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 12-18 years. * Confirmed diagnosis of Chronic Spontaneous Urticaria (CSU) according to international guidelines. * No recent use of systemic corticosteroids or immunosuppressive therapy (except short-term acute use). * Written informed consent provided by both the participant and a parent/legal guardian.
Exclusion criteria
* Presence of a neurodevelopmental disorder. * Presence of any other known chronic disease. * Presence of a disease requiring a special therapeutic diet. * Presence of an acute infection. * Presence of any food allergy. * Recent use of systemic corticosteroids, biologic agents, - immunosuppressive therapy, or high-dose antihistamines (except short-term acute use).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urticaria Activity Score (UAS7) | Baseline (Day 0), Week 4, and Week 8 | Disease activity will be assessed using the Urticaria Activity Score over 7 days (UAS7). Changes in UAS7 scores will be evaluated at baseline, Week 4 (end of intervention), and Week 8 (follow-up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urticaria Control Test (UCT) | Baseline (Day 0), Week 4, and Week 8 | Disease control will be assessed using the Urticaria Control Test (UCT). Changes in UCT scores will be evaluated at baseline, Week 4, and Week 8. |
| Dermatology Life Quality Index (CDLQI/DLQI) | Baseline (Day 0), Week 4, and Week 8 | Health-related quality of life will be assessed using the Children's Dermatology Life Quality Index (CDLQI) or the Dermatology Life Quality Index (DLQI), as appropriate for participant age. Changes in scores will be evaluated at baseline, Week 4, and Week 8. |
| Diet adherence | Weeks 2, 3, 4 and Week 8 | Dietary adherence will be assessed throughout the study. Participants assigned to the low-histamine diet will be monitored using the Low-Histamine Diet Adherence Follow-up Form, whereas participants assigned to the Mediterranean diet will be monitored using a weekly dietary adherence form based on KIDMED questionnaire items. |
| KIDMED Index | Baseline (Day 0), Week 4, and Week 8 | Adherence to the Mediterranean dietary pattern will be assessed using the KIDMED Index at baseline, Week 4, and Week 8. Changes in KIDMED scores will be evaluated throughout the study. |
Countries
Turkey (Türkiye)
Contacts
CONTACTDeniz ÖZÇEKER, Prof. Dr.
Outcome results
None listed