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NCT Number: NCT07798050

Selective Mediterranean Diet in Immune Thrombocytopenia

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).

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Key information

Conditions

Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Idiopathic Thrombocytopenic Purpura Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selective Mediterranean Diet

Behavioral

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 ITP

Drug

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.

Primary outcomes

  1. Change in platelet count

    Time frame: 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.

  2. Change in bleeding severity score

    Time frame: 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 outcomes

  1. Need for rescue therapy

    Time frame: 12 weeks

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

  2. Change in body mass index (BMI)

    Time frame: Baseline and 12 weeks

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

  3. Tolerability of the Mediterranean diet

    Time frame: 12 weeks

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

  4. Change in Fasting Blood Glucose

    Time frame: Baseline and 12 weeks

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

  5. Change in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline and 12 weeks

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

  6. Change in Lipid Profile

    Time frame: Baseline and 12 weeks

    Change in lipid profile parameters (serum total cholesterol, triglycerides, HDL, and LDL) in mg/dL from

Study contacts

Contact information is provided by the study sponsor or research team.

Yara G Mekhemer, Resident

CONTACT

[email protected]

01011923969

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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