Honey in Chronic Immune Thrombocytopenia

This study has suspended participant recruitment.
(problem with the candidate (investigator))
Sponsor:
Information provided by (Responsible Party):
mamdouh abdulmaksoud abdulrhman, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01462916
First received: October 21, 2011
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Chronic Thrombocytopenic Purpura
Dietary Supplement: honey
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effect of Honey Bee Honey Intake on Children With Chronic Immune Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • Bleeding severity [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 30
Study Start Date: October 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462916

Locations
Egypt
Pediatric Department, Faculty of Medicine, Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: mamdouh abdulmaksoud abdulrhman, professor of pediatrics, faculty of medicine, ain shams university, Ain Shams University
ClinicalTrials.gov Identifier: NCT01462916     History of Changes
Other Study ID Numbers: ITP 123
Study First Received: October 21, 2011
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ain Shams University:
honey
mucositis
bee products

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Thrombocytopenia
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Immune System Diseases
Pathologic Processes
Purpura
Signs and Symptoms
Skin Manifestations
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on October 23, 2014