Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia, Thrombocytopenia
Conditions
Keywords
Mediterranean diet, Immune thrombocytopenia, ITP, Platelet count
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALSelective Mediterranean Diet
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).
DRUGStandard Pharmacological Therapy for ITP
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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in platelet count | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for rescue therapy | 12 weeks | Proportion of patients requiring rescue therapy (corticosteroids or intravenous immunoglobulin) during the 12-week study period. |
| Change in body mass index (BMI) | Baseline and 12 weeks | Change in body mass index (BMI) in kg/m² from baseline to 12 weeks. |
| Incidence and severity of gastrointestinal adverse events related to the Mediterranean diet | 12 weeks | Frequency and severity of gastrointestinal side effects and overall tolerability of the selective Mediterranean diet regimen, assessed by patient-reported symptoms. |
| Change in Fasting Blood Glucose | Baseline and 12 weeks | Change in fasting blood glucose levels in mg/dL from baseline to 12 weeks. |
| Change in Glycated Hemoglobin (HbA1c) | Baseline and 12 weeks | Change in HbA1c percentage (%) from baseline to 12 weeks. |
| Change in Lipid Profile | Baseline and 12 weeks | Change in lipid profile parameters (serum total cholesterol, triglycerides, HDL, and LDL) in mg/dL from |
Contacts
CONTACTYara G Mekhemer, Resident
STUDY_CHAIRAhmad F thabet, prof
Internal Medicine Department, Assiut University Hospitals
Outcome results
None listed