Honey in Chronic Immune Thrombocytopenia

NCT ID: NCT01462916

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-12-31

Brief 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.

Detailed Description

Study design:

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). This design will allow the treatment effects to be measured between the study groups (namely between the different subjects) in the same study period, or period 1, as well as in the same subjects in a crossover comparison of periods 1 and 2.

Conditions

Chronic Thrombocytopenic Purpura

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

honey, no honey

honey

Intervention Type: DIETARY_SUPPLEMENT

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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Patients with chronic ITP who did not receive any treatment specific for ITP within the past 3 months

2. Who did not receive bee honey or any medication that may affect platelet number or function within the past 3 months and

3. In whom the bleeding severity will range from 1 to 3 (mild to moderate bleeding) according to Buchanan and Adix (2002).

Exclusion Criteria

1. Grade 4 bleeding severity, according Buchanan and Adix (2002) and

2. Presence of diabetes mellitus.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

mamdouh abdulmaksoud abdulrhman

OTHER

Sponsor Role: lead

Responsible Party

mamdouh abdulmaksoud abdulrhman

professor of pediatrics, faculty of medicine, ain shams university

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mamdouh Abdulrhman, Prof

Role: PRINCIPAL_INVESTIGATOR

professor

Mohsen El Alfy, prof

Role: PRINCIPAL_INVESTIGATOR

professor

Abeer Abdulmaksoud, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Abeer Saad, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor

May Said

Role: PRINCIPAL_INVESTIGATOR

Resident

Locations

Pediatric Department, Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Related Links

http://mis2.shams.edu.eg

Ain Shams University, Egypt

Other Identifiers

ITP 123

Identifier Type: -

Identifier Source: org_study_id