The effect of glutamine supplementation on serum levels of some inflammatory factors, oxidative stressو and appetite in children with respiratory infection 2-6 years
Determining the effect of glutamine on serum levels of inflammatory factors and oxidative stress in children with lower respiratory tract infection
Design
The placebo-controlled clinical trial, with parallel, double-blind, randomized groups on 40 patients. A Randomized block design and random allocation software (RAS) will be used for randomization.
Settings and conduct
This study will be conducted on 40 children aged 2-6 years with lower respiratory infection referred to Bu Ali Hospital, Ardabil, Iran. Subjects will be randomly allocated into glutamine and placebo groups. At the baseline, general information will be collected from each participant. Blood samples ( 2cc) will be collected from each patient for measurement of study outcomes. Then, the intervention group will receive a glutamine supplement of 0.5 g / kg with a tablespoon of sugar and the placebo group will receive the same amount of sugar. Evaluation of symptoms and blood sampling to measure biochemical parameters will be repeated at the end of the intervention period for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 2-6 years old, having a respiratory infection, and willingness to cooperate. Exclusion criteria: unwilling to participate in the study, the presence of chronic disease
Intervention groups
The intervention group will receive a 0.5 g/kg BW glutamine supplement with a tablespoon of sugar for five days.
The placebo group will receive a tablespoon of sugar for five days.
Main outcome variables
IL1β, tumor necrosis factor-alpha, malondialdehyde, total antioxidant capacity, and Appetite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210913052455N1
Registration date:2021-09-24, 1400/07/02
Registration timing:prospective
Last update:2021-09-24, 1400/07/02
Update count:0
Registration date
2021-09-24, 1400/07/02
Registrant information
Name
Vahideh Aghamohammadi
Name of organization / entity
Khalkhal faculty of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3242 6801
Email address
v_agamohammadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2022-01-30, 1400/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of glutamine supplementation on serum levels of some inflammatory factors, oxidative stressو and appetite in children with respiratory infection 2-6 years
Public title
The effect of glutamine supplementation in children with respiratory infection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 2 to 6 years
Having a respiratory infection
Willingness to cooperate
Exclusion criteria:
Unwilling to cooperate
Existence of chronic disease
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to the glutamine and placebo groups by randomized block design and using random allocation software (RAS, link: https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-4-26), participants in each block will be matched by gender and age.To achieve blinding the volume of each block will be considered 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
The supplement and placebo Containers will be coded by the researcher as A and B and then will be distributed to patients by a staff member who has no clinical role in the study and is unaware of the contents of the containers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Khalkhal Faculty of Medical Sciences
Street address
Shahid Mozaffar Azizi
City
Khalkhal
Province
Ardabil
Postal code
5681761351
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.ARUMS.REC.1398.122
Health conditions studied
1
Description of health condition studied
Respiratory infection
ICD-10 code
CA4Z
ICD-10 code description
Lung infections, unspecified
Primary outcomes
1
Description
Interleukin 1 beta (IL-1B)
Timepoint
At the baseline of the study and after 5 days intervention
Method of measurement
Standard kit
2
Description
Tumor necrosis factor-alpha
Timepoint
At the baseline of the study and after 5 days intervention
Method of measurement
standard kit
3
Description
malondialdehyde
Timepoint
At the baseline of the study and after 5 days intervention
Method of measurement
standard kit
4
Description
total antioxidant capacity
Timepoint
At the baseline of the study and after 5 days intervention
Method of measurement
standard kit
5
Description
Appetite
Timepoint
At the baseline of the study and after 5 days intervention
Method of measurement
The Appetite and Diet Assessment Tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Glutamine group will receive 0.5g/kg body weight with one tablespoon sugar daily for 5 days
Category
Treatment - Drugs
2
Description
Control group: placebo group will receive one tablespoon sugar daily for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali hospital, Ardabil
Full name of responsible person
Ali Nemati
Street address
Sports Square, Moallem Street , Opposite to Azadi Park , Bouali Educational and Medical Center, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
56136 43197
Phone
+98 45 3325 2252
Email
nutrition1391@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Purfarzi
Street address
Daneshgah Street
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3353 4776
Email
research@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Nemati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Daneshgah Street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 4679
Email
nutrition1391@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Nemati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Daneshgah Street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 4679
Email
nutrition1391@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Vahideh Aghamohammadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Daneshgah Steet
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 4679
Email
v_agamohammadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available