Immune ThrombocytopeniaNCT07798050
Selective Mediterranean Diet in Immune Thrombocytopenia
A study testing Selective Mediterranean Diet and Standard Pharmacological Therapy for ITP in people with Immune Thrombocytopenia and Idiopathic Thrombocytopenic Purpura, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Thrombocytopenia
- What is being tested?
- Selective Mediterranean Diet and Standard Pharmacological Therapy for ITP
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 25 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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).
Read the 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.
- Being tested
- Selective Mediterranean Diet, Standard Pharmacological Therapy for ITP
- Keywords
- Mediterranean diet, Immune thrombocytopenia, ITP, Platelet count
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Mediterranean DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet + Standard Therapy | Experimental | Participants will follow a selective Mediterranean diet regimen in addition to their usual standard treatment for immune thrombocytopenia. Receives: 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. Receives: Drug: Standard Pharmacological Therapy for ITP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Need for rescue therapy
Proportion of patients requiring rescue therapy (corticosteroids or intravenous immunoglobulin) during the 12-week study period.
Measured: 12 weeks
Change in body mass index (BMI)
Change in body mass index (BMI) in kg/m² from baseline to 12 weeks.
Measured: 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.
Measured: 12 weeks
Change in Fasting Blood Glucose
Change in fasting blood glucose levels in mg/dL from baseline to 12 weeks.
Measured: Baseline and 12 weeks
Change in Glycated Hemoglobin (HbA1c)
Change in HbA1c percentage (%) from baseline to 12 weeks.
Measured: Baseline and 12 weeks
Change in Lipid Profile
Change in lipid profile parameters (serum total cholesterol, triglycerides, HDL, and LDL) in mg/dL from
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Gamal Mekhemer omar, Assiut University
- Investigators
- Ahmad F thabet, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798050
- Sponsor's protocol ID
- ITP-MedDiet-2026
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33567733Bonaccio 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.
PubMed 24687087Provan 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.
PubMed 31770441
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07798050
- Acronym / sponsor ID
- ITP-MedDiet-2026
- Keywords
- Mediterranean diet, Immune thrombocytopenia, ITP, Platelet count
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet + Standard Therapy | Experimental | Behavioral: Selective Mediterranean Diet, Drug: Standard Pharmacological Therapy for ITPParticipants will follow a selective Mediterranean diet regimen in addition to their usual standard treatment for immune thrombocytopenia. |
| Standard Therapy Only | Active comparator | Drug: Standard Pharmacological Therapy for ITPParticipants will continue their usual standard pharmacological treatment for immune thrombocytopenia without dietary intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Mediterranean DietA 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). | Behavioural | Mediterranean Diet + Standard Therapy |
| Standard Pharmacological Therapy for ITPStandard 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. | Drug | Mediterranean Diet + Standard Therapy, Standard Therapy Only |
Primary outcome
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.
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
6 secondary outcomes
Need for rescue therapy
Time frame: 12 weeks
Change in body mass index (BMI)
Time frame: Baseline and 12 weeks
Incidence and severity of gastrointestinal adverse events related to the Mediterranean diet
Time frame: 12 weeks
Change in Fasting Blood Glucose
Time frame: Baseline and 12 weeks
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline and 12 weeks
Change in Lipid Profile
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 33567733Hernaez 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.
- Background: PubMed 24687087Bonaccio 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.
- Background: PubMed 31770441Provan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmad F thabet, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing Selective Mediterranean Diet and Standard Pharmacological Therapy for ITP in people with Immune Thrombocytopenia and Idiopathic Thrombocytopenic Purpura, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara G Mekhemer, Resident (01011923969, yara.18313231@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in platelet count (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07798050, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.