Selective Mediterranean Diet in Immune Thrombocytopenia

NCT07798050 | Not Yet Recruiting

• 1 other identifier: ITP-MedDiet-2026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Immune Thrombocytopenia; Idiopathic Thrombocytopenic Purpura; Thrombocytopenia

Keywords

Mediterranean diet; Immune thrombocytopenia; ITP; Platelet count

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Baseline and 12 weeks

Secondary Outcomes (6)

• Need for rescue therapy

  12 weeks

• Change in body mass index (BMI)

  Baseline and 12 weeks

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

  12 weeks

• Change in Fasting Blood Glucose

  Baseline and 12 weeks

• Change in Glycated Hemoglobin (HbA1c)

  Baseline and 12 weeks

Study Arms (2)

Mediterranean Diet + Standard Therapy

EXPERIMENTAL

Participants will follow a selective Mediterranean diet regimen in addition to their usual standard treatment for immune thrombocytopenia.

Behavioral: Selective Mediterranean Diet; Drug: Standard Pharmacological Therapy for ITP

Standard Therapy Only

ACTIVE COMPARATOR

Participants will continue their usual standard pharmacological treatment for immune thrombocytopenia without dietary intervention.

Drug: Standard Pharmacological Therapy for ITP

Interventions

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).

Mediterranean Diet + Standard Therapy

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.

Mediterranean Diet + Standard Therapy; Standard Therapy Only

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Hernaez A, Lassale C, Castro-Barquero S, Ros E, Tresserra-Rimbau A, Castaner O, Pinto X, Vazquez-Ruiz Z, Sorli JV, Salas-Salvado J, Lapetra J, Gomez-Gracia E, Alonso-Gomez AM, Fiol M, Serra-Majem L, Sacanella E, Razquin C, Corella D, Guasch-Ferre M, Cofan M, Estruch R. Mediterranean Diet Maintained Platelet Count within a Healthy Range and Decreased Thrombocytopenia-Related Mortality Risk: A Randomized Controlled Trial. Nutrients. 2021 Feb 8;13(2):559. doi: 10.3390/nu13020559.

  PMID: 33567733 BACKGROUND

• Bonaccio M, Di Castelnuovo A, De Curtis A, Costanzo S, Persichillo M, Donati MB, Cerletti C, Iacoviello L, de Gaetano G; Moli-sani Project Investigators. Adherence to the Mediterranean diet is associated with lower platelet and leukocyte counts: results from the Moli-sani study. Blood. 2014 May 8;123(19):3037-44. doi: 10.1182/blood-2013-12-541672. Epub 2014 Mar 31.

  PMID: 24687087 BACKGROUND

• Provan D, Arnold DM, Bussel JB, Chong BH, Cooper N, Gernsheimer T, Ghanima W, Godeau B, Gonzalez-Lopez TJ, Grainger J, Hou M, Kruse C, McDonald V, Michel M, Newland AC, Pavord S, Rodeghiero F, Scully M, Tomiyama Y, Wong RS, Zaja F, Kuter DJ. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019 Nov 26;3(22):3780-3817. doi: 10.1182/bloodadvances.2019000812.

  PMID: 31770441 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia

Interventions

Inosine Triphosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Ahmad F thabet, prof

  Internal Medicine Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Yara G Mekhemer, Resident

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Internal Medicine

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 25, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08