Honey in Idiopathic Dilated Cardiomyopathy

• ClinicalTrials.gov Identifier: NCT02987322
• Recruitment Status: Completed
• First Posted: December 8, 2016
• Last Update Posted: December 12, 2016
• Sponsor: mamdouh abdulmaksoud abdulrhman
• Information provided by (Responsible Party): mamdouh abdulmaksoud abdulrhman, Ain Shams University

Tracking Information

• First Submitted Date: November 29, 2016
• First Posted Date: December 8, 2016
• Last Update Posted Date: December 12, 2016
• Study Start Date: November 2015
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 7, 2016)

Ejection fraction % as measured by echocardiography [ Time Frame: 3 months ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02987322 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Honey in Idiopathic Dilated Cardiomyopathy
• Official Title: Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study

Brief Summary

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.

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
• Study Phase: Phase 2; Phase 3
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Idiopathic Dilated Cardiomyopathy

Intervention

Dietary Supplement: honey

Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months

Study Arms

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.

Intervention: Dietary Supplement: honey

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2016): 50
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02987322
• Other Study ID Numbers: 4472/28.9.2015
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: honey as a complementary or alternative treatment in cardiovascular diseases

• Responsible Party: mamdouh abdulmaksoud abdulrhman, Ain Shams University
• Study Sponsor: mamdouh abdulmaksoud abdulrhman
• Collaborators: Not Provided

Investigators

• Principal Investigator: Waleed Elgendy, Lecturer; Ain Shams University, Pediatric departement

• PRS Account: Ain Shams University
• Verification Date: December 2016