Mediterranean and Low-Histamine Diets for Pediatric Chronic Spontaneous Urticaria
ConditionUrticaria Chronic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorSaglik Bilimleri Universitesi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Low-Histamine Diet
Other interventionParticipants assigned to this intervention will receive a low-histamine diet in addition to standard medical treatment for 4 weeks.
Mediterranean Diet
Other interventionParticipants assigned to this intervention will receive a Mediterranean diet in addition to standard medical treatment for 4 weeks.
Treatment groups
63 Participants
are divided into 3 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Low-Histamine DietExperimental treatment 1 intervention
Group C: Mediterranean dietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Urticaria Activity Score (UAS7)
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).
Time frame
Baseline (Day 0), Week 4, and Week 8Secondary outcomes
1
Urticaria Control Test (UCT)
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.
Time frame
Baseline (Day 0), Week 4, and Week 82
Dermatology Life Quality Index (CDLQI/DLQI)
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.
Time frame
Baseline (Day 0), Week 4, and Week 83
Diet adherence
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.
Time frame
Weeks 2, 3, 4 and Week 84
KIDMED Index
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.
Time frame
Baseline (Day 0), Week 4, and Week 8Sponsors and contacts
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Source ClinicalTrials.gov