Honey in Chronic Immune Thrombocytopenia

NCT01462916 | Terminated DMC

• 1 other identifier: ITP 123
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Thrombocytopenic Purpura

Keywords

honey; mucositis; bee products

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Platelet count

  up to 24 weeks

Study Arms (1)

honey, no honey

Dietary Supplement: honey

Interventions

honey 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).

honey, no honey

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Grade 4 bleeding severity, according Buchanan and Adix (2002) and
• Presence of diabetes mellitus.

Sponsors & Collaborators

• mamdouh abdulmaksoud abdulrhman: lead

Study Sites (1)

Pediatric Department, Faculty of Medicine, Ain Shams University

Cairo, Egypt

Location

Related Links

• Ain Shams University, Egypt

MeSH Terms

Conditions

Mucositis

Interventions

Honey

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor of pediatrics, faculty of medicine, ain shams university

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: November 1, 2011
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

EG (1)