Honey in Idiopathic Dilated Cardiomyopathy

NCT02987322 | Completed Phase 2 DMC

• 1 other identifier: 4472/28.9.2015
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

honey

EXPERIMENTAL

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

Interventions

honey DIETARY_SUPPLEMENT

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

honey

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• mamdouh abdulmaksoud abdulrhman: lead

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Honey

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Officials

• Waleed Elgendy, Lecturer

  Ain Shams University, Pediatric departement

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 12, 2016

Record last verified: 2016-12