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The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A

Primary Purpose

Hepatitis A

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
honey
molasses
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis A focused on measuring honey, hepatitis A

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Previously healthy children who have Hepatitis A.They were of both sexes and aged 2 to 18 years.

Exclusion Criteria:

Patients with diabetes mellitus (DM), chronic liver diseases, autoimmune disorders, renal disorders, neurologic diseases or malignancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    honey

    molasses

    Arm Description

    Each patient in the honey group (group 1) took oral honey in a dose of 5 ml/kg/day (with a maximum dose of 150 ml/day) for four weeks.

    Each patient in the molasses (placebo) group (group 1) took molasses in a dose of 5 ml/kg/day (with a maximum dose of 150 ml/day) for four weeks.

    Outcomes

    Primary Outcome Measures

    the recovery time defined as the number of days from the start of the intervention to subsidence of symptoms and signs of hepatitis and return of liver transaminases to their normal levels.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 19, 2014
    Last Updated
    November 24, 2014
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02300792
    Brief Title
    The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A
    Official Title
    The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is a randomized, placebo controlled, double-blinded clinical trial, which included 50 children with hepatitis A. They were of both sexes and their age ranged from 2 to 18 years. The patients were randomly assigned into one of two groups; each consisted of 25 children. Each patient in the intervention group (group 1) took oral honey in a dose of 5 ml/kg/day (with a maximum dose of 150 ml/day) for four weeks, whereas patients of the placebo group (group 2) took placebo in the form of molasses. The main outcome measure was the recovery time defined as the number of days from the start of the intervention to subsidence of symptoms and signs of hepatitis and return of liver transaminases to their normal levels.
    Detailed Description
    This study is a randomized, placebo controlled double-blinded clinical trial, which was conducted at the Children's Hospital of Ain Shams university during the period from November 2013 to May 2014. Eligible patients were previously healthy children of both sexes, aged 2 to 18 years, who developed manifestations of acute hepatitis. Patients with diabetes mellitus (DM), chronic liver diseases, autoimmune disorders, renal disorders, neurologic diseases or malignancy were excluded from the study. Eighty nine eligible patients were recruited from the outpatient Clinic of the Children's Hospital of Ain Shams university and were subjected to history taking, physical examination and laboratory investigations in the form of serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum gamma gultamyltransferase (GGT), serum bilirubin (total and direct) and assay for Hepatitis A Virus IgM (HAV IgM). Only patients who had positive HAV IgM were candidates for this study. They were seventy six patients who were randomly assigned following simple randomisation procedure (computerized random numbers) to 1 of 2 groups with a 1:1 allocation ratio. During the study, a total of twenty six patients were excluded; nine patients stopped the trial because they refused to repeat blood sampling for investigations, six patients were not compliant to honey intake and ten patients lost follow up. Fifty patients, thus completed the study protocol and were included in the final analysis. Assuming the mean duration of the acute illness is 6 weeks and the mean (±SD) duration of acute illness in the intervention group is 4 (±2), a total sample size of 42 patients (21 per group) is required to have a statistical power of 90% (alpha=0. 05). Post- hoc test was used for power calculation. Each patient in the intervention group (group 1) took oral honey in a dose of 5 ml/kg/day (with a maximum dose of 150 ml/day) for four weeks. The dose of honey was empirical. Each patient in the placebo group (group 2) took 5 ml molasses/kg/day; with a maximum of 150ml/day. Molasses is a honey-like substance made when cane sugar is processed. It contains no fat and is composed mainly of sucrose, besides some fructose and glucose. The main outcome measure was the recovery time defined as the number of days from the start of the intervention to subsidence of symptoms and signs of hepatitis and return of liver transaminases to their normal levels. The main symptoms and signs of hepatitis A are fever, anorexia, nausea, vomiting, abdominal pain, dark urine, clay-colored stools and jaundice. Physical examination focused on general condition, vital data, jaundice, hepatosplenomegaly and ascites. The laboratory work up consisted of measurements of ALT, AST and GGT by kinetic method, measurement of total and direct bilirubin levels by colorimetric method, and assay of Anti-HAV IgM by ELISA. Clinical and laboratory evaluation of each patient was done at baseline (0), 2nd week and 4th week (endpoint).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis A
    Keywords
    honey, hepatitis A

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    honey
    Arm Type
    Active Comparator
    Arm Description
    Each patient in the honey group (group 1) took oral honey in a dose of 5 ml/kg/day (with a maximum dose of 150 ml/day) for four weeks.
    Arm Title
    molasses
    Arm Type
    Placebo Comparator
    Arm Description
    Each patient in the molasses (placebo) group (group 1) took molasses in a dose of 5 ml/kg/day (with a maximum dose of 150 ml/day) for four weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    honey
    Intervention Description
    Each patient in the intervention group (group 1) took oral honey in a dose of 5 ml/kg/day (with a maximum dose of 150 ml/day) for four weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    molasses
    Other Intervention Name(s)
    placebo
    Intervention Description
    Each patient in the molasses (placebo) group took 5 ml molasses/kg/day for four weeks, with a maximum of 150 ml/day
    Primary Outcome Measure Information:
    Title
    the recovery time defined as the number of days from the start of the intervention to subsidence of symptoms and signs of hepatitis and return of liver transaminases to their normal levels.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Previously healthy children who have Hepatitis A.They were of both sexes and aged 2 to 18 years. Exclusion Criteria: Patients with diabetes mellitus (DM), chronic liver diseases, autoimmune disorders, renal disorders, neurologic diseases or malignancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mamdouh A Abdulrhman, Professor
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A

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