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
About this trial
This is an interventional treatment trial for Hepatitis A focused on measuring honey, hepatitis A
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
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
NCT ID
NCT02300792
First Posted
November 19, 2014
Last Updated
November 24, 2014
Sponsor
Ain Shams University
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
Learn more about this trial
The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A
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