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