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CompletedNCT03551613Updated Jun 11, 2018

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

An interventional study of honey supplementation in Malnourished Infants and Childern, sponsored by Ain Shams University. Completed. Open to participants aged 6 Months to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-11.

Sponsored by Ain Shams University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Dec 2016, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
6 Months to 3 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Malnourished Infants and Childern

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 75 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 3 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

simple malnutrition

Exclusion criteria

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 .

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (actual)

Study arms

  • Active comparator
    honey group

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

    Dietary Supplement: honey supplementation

  • Placebo comparator
    malnourished control group

    no honey supplementation only nutrition rehabilitation

    Dietary Supplement: honey supplementation

  • No intervention
    healthy children

    healthy children with no suplementation

Interventions

  • Dietary supplementhoney supplementation

    honey supplementation

06

What researchers measure

Primary outcomes

  1. serum leptin

    effect of honey supplement on serum leptin in malnourished patients

    Time frame: 2 month duration of honey supplementation

  2. anthropometric measurements

    effect of honey on growth assessed by anthropomerty

    Time frame: 2 month duration of honey supplementation

Secondary outcomes

  1. 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

    Time frame: 2 month duration of honey supplementation

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03551613
Lead sponsor
Ain Shams University
Responsible party
yasmin gamal el gendy (Lecturer of Pediatrics, Ain Shams University) — Principal investigator
First posted
Jun 11, 2018
Start date
Dec 12, 2016
Primary completion
Nov 12, 2017
Completion
Feb 25, 2018
Last update
Jun 11, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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