Honey in Chronic Immune Thrombocytopenia

Sponsor

mamdouh abdulmaksoud abdulrhman (Other)

Overall Status

Terminated

CT.gov ID

NCT01462916

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Thrombocytopenic Purpura	Dietary Supplement: honey

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.

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Effect of Honey Bee Honey Intake on Children With Chronic Immune Thrombocytopenia

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
honey, no honey	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).

Arm

Intervention/Treatment

honey, no honey

Dietary Supplement: honey

Outcome Measures

Primary Outcome Measures

Bleeding severity [up to 24 weeks]
Bleeding severity will be assessed clinically at least twice weekly and whenever indicated through telephone contact with parents or guardian At least twice weekly for 24 weeks

Secondary Outcome Measures

Platelet count [up to 24 weeks]
Both bleeding severity and platelet count will be assessed at least twice weekly and whenever indicated through telephone contact with parents or guardian At least twice weekly for 24 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with chronic ITP who did not receive any treatment specific for ITP within the past 3 months
Who did not receive bee honey or any medication that may affect platelet number or function within the past 3 months and
In whom the bleeding severity will range from 1 to 3 (mild to moderate bleeding) according to Buchanan and Adix (2002).