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

NCT ID: NCT03551613

Last Updated: 2018-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-12

Study Completion Date

2018-02-25

Brief Summary

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This study was a randomized single blinded case control prospective intervention study.

Detailed Description

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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.

Conditions

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Malnourished Infants and Childern

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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honey group

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

Group Type ACTIVE_COMPARATOR

honey supplementation

Intervention Type DIETARY_SUPPLEMENT

honey supplementation

malnourished control group

no honey supplementation only nutrition rehabilitation

Group Type PLACEBO_COMPARATOR

honey supplementation

Intervention Type DIETARY_SUPPLEMENT

honey supplementation

healthy children

healthy children with no suplementation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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honey supplementation

honey supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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 .
Minimum Eligible Age

6 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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yasmin gamal el gendy

Lecturer of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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6879990

Identifier Type: -

Identifier Source: org_study_id

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