Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02300792
Study type Interventional
Source Ain Shams University
Contact
Status Completed
Phase Phase 2
Start date November 2013
Completion date November 2014

See also
  Status Clinical Trial Phase
Withdrawn NCT03445416 - Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men N/A
Completed NCT01949857 - The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines Phase 4
Completed NCT00313950 - Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine Phase 4
Completed NCT00139139 - A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A N/A
Completed NCT00197171 - Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine Phase 3
Completed NCT00139113 - Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children Phase 4
Completed NCT03312699 - Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Phase 1
Completed NCT03855176 - Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients Phase 4
Completed NCT00197002 - Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age Phase 3
Withdrawn NCT02605538 - Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively N/A
Completed NCT04638335 - What is the Anti-HAV Seroprevalence of Travelers >60 Years or Having Lived in a Tropical Country for >5 Years
Completed NCT00197015 - Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children Phase 3
Active, not recruiting NCT06058416 - Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old Phase 4
Completed NCT01453348 - Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine Phase 3
Completed NCT01865968 - Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults Phase 4
Completed NCT02002065 - The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children N/A
Terminated NCT00119743 - A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine Phase 3
Completed NCT01000324 - Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult Phase 4
Completed NCT00289731 - Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc Phase 4
Completed NCT02601040 - Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines Phase 4