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

NCT02300792 | Completed Phase 2 DMC

• 1 other identifier: 11/013
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis A

Keywords

honey, hepatitis A

Outcome Measures

Primary Outcomes (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.

  4 weeks

Study Arms (2)

honey

ACTIVE COMPARATOR

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; Dietary Supplement: molasses

molasses

PLACEBO COMPARATOR

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; Dietary Supplement: molasses

Interventions

honey DIETARY_SUPPLEMENT

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.

honey; molasses

molasses DIETARY_SUPPLEMENT

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

Also known as: placebo

honey; molasses

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Hepatitis A

Interventions

Honey; Molasses

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mamdouh A Abdulrhman, Professor

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 26, 2014

Record last verified: 2014-11