Clinical trial NCT01462916: Honey in Chronic Immune Thrombocytopenia
Official title: Effect of Honey Bee Honey Intake on Children With Chronic Immune Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Thrombocytopenic Purpura
Keywords: honey
mucositis
bee products
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2011-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Bleeding severity
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Platelet count
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Department, Faculty of Medicine, Ain Shams University
Study officials:
affiliation: professor
name: Mamdouh Abdulrhman, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: professor
name: Mohsen El Alfy, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor
name: Abeer Abdulmaksoud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor
name: Abeer Saad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Resident
name: May Said
role: PRINCIPAL_INVESTIGATOR
References: