Selective Mediterranean Diet in Immune Thrombocytopenia

The Effect of a Selective Mediterranean Diet Regimen on Platelet Count and Clinical Outcomes in Patients With Primary Immune Thrombocytopenia: A Randomized Controlled Trial

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).

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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