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Honey in Chronic Immune Thrombocytopenia

NCT01462916 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2018-01-09

No results posted yet for this study

Summary

Based on the assumption that honey may have an immunomodulatory effect, the aim of our present study will be to verify whether the intake of honey, as a natural substance, in patients with chronic Immune Thrombocytopenia (ITP) could affect the platelet number and hence could affect the bleeding severity. Thirty patients suffering from chronic ITP will be recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University, Cairo, Egypt. The diagnosis of ITP will be based on the presence of isolated thrombocytopenia with a peripheral blood platelet count less than 100 x 109/L, and absence of any obvious initiating and/or underlying cause of the thrombocytopenia. Chronic ITP is defined as ITP for at least 12 months. The age of the patients will range from 5 to 15 years, and they will be of both sexes. This study was approved by the local Ethics Committee of the Pediatric Department of Ain Shams University, and an informed consent to participate in this study will be obtained from at least one parent of each patient. Furthermore, an ascent form will be obtained from each patient above 7 years of age.

Conditions

  • Chronic Thrombocytopenic Purpura

Interventions

DIETARY_SUPPLEMENT

honey

A crossover design (two 12-weeks intervention periods) will be used to measure treatment effects. The subjects will be randomized into two groups (intervention to control \[I/C\] and control to intervention \[C/I\] groups). Each study group will have 15 subjects. The subjects in the I/C group will consume 2 ml honey/kg/dose (maximum 50 ml/dose), twice weekly in the first 12-week period (period 1) while the subjects in the C/I group will not receive honey as a Control in period 1. After period 1 the subjects of each group will exchange their protocol for the following 12-week period (period 2).

Sponsors & Collaborators

  • mamdouh abdulmaksoud abdulrhman

    lead OTHER

Principal Investigators

  • Mamdouh Abdulrhman, Prof · professor

  • Mohsen El Alfy, prof · professor

  • Abeer Abdulmaksoud, MD · Assistant Professor

  • Abeer Saad, MD · Assistant professor

  • May Said · Resident

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01462916 on ClinicalTrials.gov