Honey in Idiopathic Dilated Cardiomyopathy

Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study

Background: Honey, as a natural product produced by honey bees, has anti-oxidant, anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that honey might have positive effects on cardiovascular diseases.

Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2 to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly assigned into two equal groups: the honey group and the control group. In the honey group, honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional treatment of IDC. The patients in the control group received only their standard treatment, without honey. The main outcome measure was the percent change in the ejection fraction (EF) and the fraction shortening (FS) shown in echocardiography.

Study Overview

• Status: Completed
• Conditions: Idiopathic Dilated Cardiomyopathy
• Intervention / Treatment: Dietary supplement: honey

Detailed Description

Background: Honey, as a natural product produced by honey bees, has anti-oxidant, anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that honey might have positive effects on cardiovascular diseases.

Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2 to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly assigned into two equal groups: the honey group and the control group. In the honey group, honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional treatment of IDC. The patients in the control group received only their standard treatment, without honey. The main outcome measure was the percent change in the ejection fraction (EF) and the fraction shortening (FS) shown in echocardiography. Patients in each group were subjected to history taking, clinical examination and investigations, including ECG and echocardiography at baseline and end of the study. Patients continued their standard treatment during the study. The honey used in the study was subjected to physicochemical analysis before use, and it was kept in closed containers away from light until the time of administration.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Echocardiographic diagnosis of dilated cardiomyopathy (DCM), based on the presence of left ventricular enlargement and systolic dysfunction with an ejection fraction <45%.
2. The echocardiographic findings included left ventricular dilatation and systolic dysfunction, with or without mitral regurgitation

Exclusion Criteria:

1. Other types of cardiomyopathy
2. Systemic or chronic illness, including cancer, endocrine disorders and sepsis
3. Children with diabetes mellitus
4. Ischemic heart disease diagnosed by coronary angiography or a history of myocardial infarction
5. Systemic hypertension with a blood pressure >170/100 mm Hg -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: honey; Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months for the patients in the honey group.	Dietary supplement: honey; Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ejection fraction % as measured by echocardiography	The main outcome measure is the average increase or decrease of the ejection fraction (expressed as percentage), which refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction.	3 months

Collaborators and Investigators

• Sponsor: mamdouh abdulmaksoud abdulrhman
• Investigators: Principal Investigator: Waleed Elgendy, Lecturer, Ain Shams University, Pediatric departement

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Estimate): December 12, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: 4472/28.9.2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: honey as a complementary or alternative treatment in cardiovascular diseases