The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 2

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).
    

Intervention name(s): honey; molasses
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; Each patient in the molasses (placebo) group took 5 ml molasses/kg/day for four weeks, with a maximum of 150 ml/day
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: honey, hepatitis A