Health TrialsbyHealthPanel

Selective Mediterranean Diet in Immune Thrombocytopenia

ConditionsImmune ThrombocytopeniaIdiopathic Thrombocytopenic PurpuraThrombocytopenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Secondary thrombocytopenia

Pregnancy or lactation

Uncontrolled diabetes mellitus, chronic kidney disease, or hepatic failure

Strict dietary regimens for other medical conditions

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Mediterranean Diet + Standard TherapyExperimental treatment 2 interventions
Group B: Standard Therapy OnlyActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: