Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300792
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
mamdouh abdulmaksoud abdulrhman, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Hepatitis A Dietary Supplement: honey Dietary Supplement: molasses Phase 2

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: honey
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.
Dietary Supplement: honey
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.

Dietary Supplement: molasses
Each patient in the molasses (placebo) group took 5 ml molasses/kg/day for four weeks, with a maximum of 150 ml/day
Other Name: placebo

Placebo Comparator: molasses
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.
Dietary Supplement: honey
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.

Dietary Supplement: molasses
Each patient in the molasses (placebo) group took 5 ml molasses/kg/day for four weeks, with a maximum of 150 ml/day
Other Name: placebo




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300792


Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: Mamdouh A Abdulrhman, Professor Ain Shams University

Layout table for additonal information
Responsible Party: mamdouh abdulmaksoud abdulrhman, professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT02300792     History of Changes
Other Study ID Numbers: 11/013
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by mamdouh abdulmaksoud abdulrhman, Ain Shams University:
honey, hepatitis A

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections