Selective Mediterranean Diet in Immune Thrombocytopenia

September 1, 2026 updated by: Yara Gamal Mekhemer omar, Assiut University

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediterranean Diet + Standard Therapy
Participants will follow a selective Mediterranean diet regimen in addition to their usual standard treatment for immune thrombocytopenia.
Behavioral: Selective 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).
Drug: Standard 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.
Active Comparator: Standard Therapy Only
Participants will continue their usual standard pharmacological treatment for immune thrombocytopenia without dietary intervention.
Drug: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks
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
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for rescue therapy
Time Frame: 12 weeks
Proportion of patients requiring rescue therapy (corticosteroids or intravenous immunoglobulin) during the 12-week study period.
12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
Change in Glycated Hemoglobin (HbA1c)
Time Frame: Baseline and 12 weeks
Change in HbA1c percentage (%) from baseline to 12 weeks.
Baseline and 12 weeks
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
Baseline and 12 weeks
Incidence and severity of gastrointestinal adverse events related to 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Ahmad F thabet, prof, Internal Medicine Department, Assiut University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

March 25, 2028

Study Registration Dates

First Submitted

August 25, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITP-MedDiet-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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