ClinicalTrials.gg
Not yet recruitingNCT07798050Updated Sep 3, 2026

Selective Mediterranean Diet in Immune Thrombocytopenia

An interventional study of Selective Mediterranean Diet and Standard Pharmacological Therapy for ITP in Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura and Thrombocytopenia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Purpura, Thrombocytopenic, Idiopathic by Assiut University — 7 open to participants now, 7 under way, none of them phase 3. Purpura, Thrombocytopenic, Idiopathic · Assiut University.

Started
2026
the only one that year
No phase
3 of 15
2 open now
Registered
15th of 15
by date

Among the 15 studies in Purpura, Thrombocytopenic, Idiopathic by Assiut University, this one is the only one that started in 2026, is one of 3 with no phase, and was the 15th registered.

Purpura, Thrombocytopenic, Idiopathic

503 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.

Browse Purpura, Thrombocytopenic, Idiopathic studies →

Open to participants now

7 of the 15 studies in Purpura, Thrombocytopenic, Idiopathic by Assiut University are open now, in 1 country. Recruiting first, the newest first:

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By country, each count listing its studies:

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Where they have run

Who these studies take

Of the 102 Purpura, Thrombocytopenic, Idiopathic studies recruiting now, 48 (47%) set no upper age limit and 42 (41%) stop at 75 or younger; 27 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Immune Thrombocytopenia
  • Idiopathic Thrombocytopenic Purpura
  • Thrombocytopenia

Keywords

  • Mediterranean diet
  • Immune thrombocytopenia
  • ITP
  • Platelet count
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-60 years
  • Diagnosis of primary immune thrombocytopenia according to American Society of Hematology (ASH) criteria
  • count \< 100 × 10⁹/L at enrollment
  • Willingness to comply with the dietary protocol and follow-up schedule

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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 · Drug: Standard Pharmacological Therapy for ITP

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 12 weeks

  2. 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

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Need for rescue therapy

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

    Time frame: 12 weeks

  2. Change in body mass index (BMI)

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

    Time frame: Baseline and 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. Change in Fasting Blood Glucose

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

    Time frame: Baseline and 12 weeks

  5. Change in Glycated Hemoglobin (HbA1c)

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

    Time frame: Baseline and 12 weeks

  6. Change in Lipid Profile

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

    Time frame: Baseline and 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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 33567733 ↗
  • 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. PubMed 24687087 ↗
  • 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. PubMed 31770441 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Sep 1, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Mar 25, 2028
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07798050
Lead sponsor
Assiut University
Responsible party
Yara Gamal Mekhemer omar (Resident Physician, Department of Internal Medicine, Assiut University) — Principal investigator
First posted
Sep 1, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Mar 25, 2028 (estimated)
Last update
Sep 3, 2026

Study contacts

Yara G Mekhemer, Resident
Contact
yara.18313231@med.aun.edu.eg
01011923969
Ahmad F thabet, prof
study chair · Internal Medicine Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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