The Effect of a Selective Mediterranean Diet Regimen on Platelet Count and Clinical Outcomes in Patients With Primary Immune Thrombocytopenia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in platelet count
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of a selective Mediterranean diet regimen, used as an adjunct to standard therapy, on platelet count and bleeding-related outcomes in adult patients with primary immune thrombocytopenia (ITP).
详细描述
Primary immune thrombocytopenia (ITP) is an autoimmune disorder characterized by immune-mediated platelet destruction and impaired platelet production. Emerging evidence suggests that dietary patterns, particularly the Mediterranean diet, may influence immune regulation, systemic inflammation, and gut microbiota, which could affect the course of autoimmune diseases including ITP.
This randomized controlled trial will assess the effect of a selective Mediterranean diet-based regimen as an adjunct to standard pharmacological treatment on clinical and hematological outcomes in patients with primary ITP. Participants will continue their usual ITP medications throughout the study. The primary focus will be on changes in platelet count and bleeding severity over 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •Diagnosis of primary immune thrombocytopenia according to American Society of Hematology (ASH) criteria
- •Platelet count < 100 × 10⁹/L at enrollment
- •Willingness to comply with the dietary protocol and follow-up schedule
排除标准
- •Secondary thrombocytopenia
- •Pregnancy or lactation
- •Uncontrolled diabetes mellitus, chronic kidney disease, or hepatic failure
- •Strict dietary regimens for other medical conditions
- •History of bariatric surgery or malabsorption syndromes
- •Known food allergies to core Mediterranean diet components
- •Active chemotherapy or splenectomy within the last 3 months
- •Prednisone/prednisolone ≥ 20 mg/day (or equivalent) at enrollment or recent dose adjustment within 2 weeks
- •Poor compliance or inability to attend follow-up visits
研究组 & 干预措施
Mediterranean Diet + Standard Therapy
Participants will follow a selective Mediterranean diet regimen in addition to their usual standard treatment for immune thrombocytopenia.
干预措施: Selective Mediterranean Diet (Behavioral)
Mediterranean Diet + Standard Therapy
Participants will follow a selective Mediterranean diet regimen in addition to their usual standard treatment for immune thrombocytopenia.
干预措施: Standard Pharmacological Therapy for ITP (Drug)
Standard Therapy Only
Participants will continue their usual standard pharmacological treatment for immune thrombocytopenia without dietary intervention.
干预措施: Standard Pharmacological Therapy for ITP (Drug)
结局指标
主要结局
Change in platelet count
时间窗: Baseline and 12 weeks
Change in platelet count (×10⁹/L) from baseline to 12 weeks, comparing the Mediterranean diet intervention group with the control group. Platelet count will be measured by automated hematology analyzer and confirmed by peripheral blood film.
Change in bleeding severity score
时间窗: Baseline and 12 weeks
Change in bleeding severity assessed by the ITP-BAT or WHO Bleeding Scale from baseline to 12 weeks. Higher scores indicate more severe bleeding
次要结局
- Need for rescue therapy(12 weeks)
- Change in body mass index (BMI)(Baseline and 12 weeks)
- Tolerability of the Mediterranean diet(12 weeks)
- Change in Fasting Blood Glucose(Baseline and 12 weeks)
- Change in Glycated Hemoglobin (HbA1c)(Baseline and 12 weeks)
- Change in Lipid Profile(Baseline and 12 weeks)
- Incidence and severity of gastrointestinal adverse events related to the Mediterranean diet(12 weeks)
研究者
Yara Gamal Mekhemer omar
Resident Physician, Department of Internal Medicine
Assiut University