Selective Mediterranean Diet in Immune Thrombocytopenia

N/ANot Yet RecruitingNCT07798050

Assiut University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura Thrombocytopenia

Interventions

Selective Mediterranean DietBEHAVIORAL

A selective Mediterranean diet regimen based on Mediterranean diet principles with stepwise elimination and reintroduction of certain foods, as an adjunct to standard pharmacological treatment for immune thrombocytopenia (ITP).

Standard Pharmacological Therapy for ITPDRUG

Standard pharmacological treatment for primary immune thrombocytopenia as prescribed by the treating physician, including corticosteroids (e.g., dexamethasone, prednisone) or intravenous immunoglobulin (IVIg), according to standard clinical guidelines.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in platelet count

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.

Time frame: Baseline and 12 weeks

Change in bleeding severity score

Change in bleeding severity assessed by the ITP-BAT or WHO Bleeding Scale from baseline to 12 weeks. Higher scores indicate more severe bleeding

Time frame: Baseline and 12 weeks

Secondary Outcomes

Need for rescue therapy

Proportion of patients requiring rescue therapy (corticosteroids or intravenous immunoglobulin) during the 12-week study period.

Time frame: 12 weeks

Change in body mass index (BMI)

Change in body mass index (BMI) in kg/m² from baseline to 12 weeks.

Time frame: Baseline and 12 weeks

Incidence and severity of gastrointestinal adverse events related to the Mediterranean diet

Frequency and severity of gastrointestinal side effects and overall tolerability of the selective Mediterranean diet regimen, assessed by patient-reported symptoms.

Time frame: 12 weeks

Change in Fasting Blood Glucose

Change in fasting blood glucose levels in mg/dL from baseline to 12 weeks.

Time frame: Baseline and 12 weeks

Change in Glycated Hemoglobin (HbA1c)

Change in HbA1c percentage (%) from baseline to 12 weeks.

Central Contacts

Yara G Mekhemer, Resident

CONTACT

01011923969 yara.18313231@med.aun.edu.eg

Data from ClinicalTrials.gov

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