Honey in Idiopathic Dilated Cardiomyopathy

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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 Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Ejection fraction % as measured by echocardiography


Condition

Idiopathic Dilated Cardiomyopathy

Intervention

honey

Study Arms / Comparison Groups

 honey
Description:  Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months for the patients in the honey group.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

50

Start Date

November 2015

Completion Date

November 2016

Primary Completion Date

May 2016

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 -
      

Gender

All

Ages

2 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Waleed Elgendy, Lecturer, , 



Administrative Informations


NCT ID

NCT02987322

Organization ID

4472/28.9.2015


Responsible Party

Sponsor-Investigator

Study Sponsor

mamdouh abdulmaksoud abdulrhman


Study Sponsor

Waleed Elgendy, Lecturer, Principal Investigator, Ain Shams University, Pediatric departement


Verification Date

December 2016