Investigation of the Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab Treatment in Patients With Chronic Spontaneous Urticaria
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Disease activity scores (UAS7, UCT) and urticaria quality of life questionnaire (CU-Q2oL)
研究概览
简要总结
Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative stress with CSU presence, disease activity, and response to omalizumab. Adults with active CSU and age/BMI-matched healthy controls will provide non-consecutive 3-day dietary records (two weekdays and one weekend day). Dietary antioxidant capacity will be calculated using ORAC metrics via BeBiS software. Oxidative stress biomarkers (total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde, and advanced oxidation protein products) will be measured from venous blood samples. CSU disease activity will be assessed using UAS7 and UCT, along with an urticaria quality of life questionnaire. In CSU patients who receive omalizumab as clinically indicated, assessments will be repeated after 3 months to evaluate treatment response and associated changes in diet and oxidative stress markers.
详细描述
This is an observational, case-control study including 58 adults (18-65 years) with active chronic spontaneous urticaria recruited from a dermatology outpatient clinic and 58 age- and BMI-matched healthy volunteers. Demographic/clinical data and comorbidities will be recorded. Dietary intake will be captured using three non-consecutive 24-hour food consumption records (two weekdays, one weekend day). Food portions will be estimated using a standardized food photo catalogue and analyzed with BeBiS 9.0 to compute macro/micronutrients, glycemic index/load, and dietary antioxidant capacity using ORAC. Venous blood will be used to measure total oxidant status (TOS/TOK), total antioxidant status (TAS/TAK), advanced oxidation protein products (AOPP), and malondialdehyde (MDA), and to calculate oxidative stress index (OSI). In CSU patients, disease activity will be evaluated using UAS7 and the Urticaria Control Test (UCT), as well as an urticaria quality of life questionnaire. CSU patients with a clinical indication for omalizumab will be re-evaluated after 3 months, repeating dietary records, biomarker measurements, and clinical scores to assess treatment response.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •CSU group: diagnosis of chronic spontaneous urticaria, active CSU, and written informed consent
- •Control group: healthy volunteers with similar characteristics (age/BMI-matched)
排除标准
- •Additional dermatologic, metabolic, endocrinologic, systemic inflammatory disease; malignancy (diagnosis or suspicion)
- •Use within last 3 months of anti-inflammatory drugs or drugs that may affect serum glucose/lipids
- •Special diet/nutrition status; antioxidant supplement use
- •Smoking or alcohol use
- •Pregnant or breastfeeding
研究组 & 干预措施
Cohort 1: Chronic Spontaneous Urticaria (CSU) Patients
58 adults with active CSU
Cohort 2: Healthy Controls
58 healthy volunteers matched by age and BMI
结局指标
主要结局
Disease activity scores (UAS7, UCT) and urticaria quality of life questionnaire (CU-Q2oL)
时间窗: Baseline
Disease activity and control will be assessed in CSU patients only using the Urticaria Activity Score over 7 days (UAS7) and Urticaria Control Test (UCT). Quality of life will be assessed in CSU patients only using an urticaria quality of life questionnaire (CU-Q2oL)
Oxidative stress biomarkers (TOK, TAK, AOPP, MDA; OSI calculated)
时间窗: Baseline
From routine venous blood samples, Total Oxidant Capacity (TOK), Total Antioxidant Capacity (TAK), Advanced Oxidation Protein Products (AOPP), and Malondialdehyde (MDA) will be measured; Oxidative Stress Index (OSI) will be calculated as the TOK/TAK ratio.
Dietary intake / dietary antioxidant capacity based on 3-day dietary record
时间窗: Baseline
Dietary intake will be captured using three non-consecutive 24-hour dietary records (two weekdays, one weekend day). Dietary antioxidant capacity will be calculated using Oxygen Radical Absorbance Capacity (ORAC) with BeBiS 9.0 (Nutrition Information System).
次要结局
- Change in urticaria disease activity score (UAS7: Urticaria Activity Score over 7 days), urticaria control (UCT: Urticaria Control Test) and urticaria-related quality of life questionnaire score (CU-Q2oL)(Baseline to 3 months (after initiation of omalizumab))
- Change in oxidative stress biomarkers in venous blood (TOK, TAK, AOPP, MDA, OSI)(Baseline to 3 months after initiation of omalizumab)
研究者
Emine Ecem Hakkoymaz
MD
Istanbul Training and Research Hospital