Honey in Chronic Immune Thrombocytopenia

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Thrombocytopenic Purpura
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Pediatric Department, Faculty of Medicine, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Thirty patients suffering from chronic immune thrombocytopenic purpura (ITP) will be recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University,Egypt. The age of the patients will range from 5 to 15 years, and they will be of both sexes.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding severity	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	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet count	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	up to 24 weeks

Collaborators and Investigators

• Sponsor: mamdouh abdulmaksoud abdulrhman
• Investigators: Principal Investigator: Mamdouh Abdulrhman, Prof, Professor; Principal Investigator: Mohsen El Alfy, prof, Professor; Principal Investigator: Abeer Abdulmaksoud, MD, Assistant professor; Principal Investigator: Abeer Saad, MD, Assistant professor; Principal Investigator: May Said, Resident

Publications and helpful links

Helpful Links

• Ain Shams University, Egypt

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: mucositis; honey; bee products
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: ITP 123