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Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children

Primary Purpose

Malnourished Infants and Childern

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
honey supplementation
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnourished Infants and Childern

Eligibility Criteria

6 Months - 3 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

simple malnutrition

Exclusion Criteria:

cancer, sepsis, endocrine disorders, neurologic disorders, diabetes mellitus, heart failure renal failure liver cell failure. malabsorption disorders, chromosomal aberrations, inborn errors of metabolism cerebral palsy .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Placebo Comparator

    No Intervention

    Arm Label

    honey group

    malnourished control group

    healthy children

    Arm Description

    malnourished children supplemented with honey in dose of 2ml/kg

    no honey supplementation only nutrition rehabilitation

    healthy children with no suplementation

    Outcomes

    Primary Outcome Measures

    serum leptin
    effect of honey supplement on serum leptin in malnourished patients
    anthropometric measurements
    effect of honey on growth assessed by anthropomerty

    Secondary Outcome Measures

    frequency of infection and total caloric intake in the honey group
    compare effect of honey on frequency of infection in supplemented group compared to malnourished on rehabilitation

    Full Information

    First Posted
    March 19, 2018
    Last Updated
    May 28, 2018
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03551613
    Brief Title
    Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children
    Official Title
    Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 12, 2016 (Actual)
    Primary Completion Date
    November 12, 2017 (Actual)
    Study Completion Date
    February 25, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study was a randomized single blinded case control prospective intervention study.
    Detailed Description
    Fifty infants and children of both sexes, aged 6 months to 3 years, with malnutrition were consecutively recruited from the Nutrition Clinic of the Pediatric Hospital, Ain Shams University. These patients were randomly assigned following a simple randomization procedure (computerized random numbers) to either the honey group (group 1) or the malnourished control group (group 2) with a 1:1 allocation ratio. Each group consisted of 25 patients. An additional 25 healthy infants and children with the same age range and of both sexes were recruited from the outpatient pediatric clinic of Ain Shams University, Egypt as a healthy control group (group 3). The inclusion criteria was in whom the under nutrition is caused by inadequate energy intake, while the exclusion criteria included markedly ill patients, and children with chronic or severe systemic illness or malabsorption disorders, chromosomal aberrations, inborn errors of metabolism and cerebral palsy. History taking with special emphasis on the dietetic history, history of any disease that might interfere with the nutrient intake or their use by the body and history of any acute or chronic illness. And full body Examination which include anthropometric measurements weight, height and mid arm circumference. Each patient in the intervention group or honey group or group 1 took oral honey in a dose of 2ml/kg/day for 8 weeks; the calculated dose of honey was dissolved in water with a ratio of 1: 3, respectively, and then ingested by the patient before breakfast.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnourished Infants and Childern

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    honey group
    Arm Type
    Active Comparator
    Arm Description
    malnourished children supplemented with honey in dose of 2ml/kg
    Arm Title
    malnourished control group
    Arm Type
    Placebo Comparator
    Arm Description
    no honey supplementation only nutrition rehabilitation
    Arm Title
    healthy children
    Arm Type
    No Intervention
    Arm Description
    healthy children with no suplementation
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    honey supplementation
    Intervention Description
    honey supplementation
    Primary Outcome Measure Information:
    Title
    serum leptin
    Description
    effect of honey supplement on serum leptin in malnourished patients
    Time Frame
    2 month duration of honey supplementation
    Title
    anthropometric measurements
    Description
    effect of honey on growth assessed by anthropomerty
    Time Frame
    2 month duration of honey supplementation
    Secondary Outcome Measure Information:
    Title
    frequency of infection and total caloric intake in the honey group
    Description
    compare effect of honey on frequency of infection in supplemented group compared to malnourished on rehabilitation
    Time Frame
    2 month duration of honey supplementation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: simple malnutrition Exclusion Criteria: cancer, sepsis, endocrine disorders, neurologic disorders, diabetes mellitus, heart failure renal failure liver cell failure. malabsorption disorders, chromosomal aberrations, inborn errors of metabolism cerebral palsy .

    12. IPD Sharing Statement

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    Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children

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