Malnourished Infants and ChildernNCT03551613
Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children
A study testing honey supplementation in people with Malnourished Infants and Childern, run by Ain Shams University.
Trial summary
This study was a randomized single blinded case control prospective intervention study. Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnourished Infants and Childern
- What is being tested?
- honey supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2016to 25 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- simple malnutrition
Who cannot join
- 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 .
About this study
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.
- Conditions
- Malnourished Infants and Childern
- Being tested
- honey supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
honey supplementationDietary supplement
honey supplementation
| Study group | Role | What they receive |
|---|---|---|
| honey group | Active comparator | malnourished children supplemented with honey in dose of 2ml/kg Receives: Dietary Supplement: honey supplementation |
| malnourished control group | Placebo comparator | no honey supplementation only nutrition rehabilitation Receives: Dietary Supplement: honey supplementation |
| healthy children | No intervention | healthy children with no suplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum leptin
effect of honey supplement on serum leptin in malnourished patients
Measured: 2 month duration of honey supplementation
anthropometric measurements
effect of honey on growth assessed by anthropomerty
Measured: 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
Measured: 2 month duration of honey supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start12 Dec 2016
- Primary completion12 Nov 2017
- Study completion25 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnourished Infants and ChildernStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasmin gamal el gendy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551613
- Sponsor's protocol ID
- 6879990
- Status last verified
- May 2018
- First submitted
- 19 Mar 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children
- ClinicalTrials.gov ID
- NCT03551613
- Acronym / sponsor ID
- 6879990
- Conditions
- Malnourished Infants and Childern
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 25 Feb 2018 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| honey group | Active comparator | Dietary Supplement: honey supplementationmalnourished children supplemented with honey in dose of 2ml/kg |
| malnourished control group | Placebo comparator | Dietary Supplement: honey supplementationno honey supplementation only nutrition rehabilitation |
| healthy children | No intervention | –healthy children with no suplementation |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- simple malnutrition
Key exclusion criteria (1 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| honey supplementationhoney supplementation | Dietary supplement | honey group, malnourished control group |
Primary outcome
serum leptin
Time frame: 2 month duration of honey supplementation
effect of honey supplement on serum leptin in malnourished patients
anthropometric measurements
Time frame: 2 month duration of honey supplementation
effect of honey on growth assessed by anthropomerty
1 secondary outcome
frequency of infection and total caloric intake in the honey group
Time frame: 2 month duration of honey supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing honey supplementation in people with Malnourished Infants and Childern, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum leptin (time frame: 2 month duration of honey supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.