Determining the effect of supplementation with egg white protein on the growth of malnourished children
Design
Experimental group with a sample size of 23
Settings and conduct
Children 3 to 6 years old with mild to severe malnutrition referred to the medical centers of Shiraz University of Medical Sciences, with the completion of the consent form by the parents and under the supervision of a physician, the intervention process begins for six months. Patients perform anthropometric measurements and required questionnaires before and after the intervention to evaluate the markers. Patients in the intervention group calculated the amount of egg white protein required for each child based on current weight at the rate of 1 gram per kilogram of body weight and a packet of egg white protein powder was given along with the necessary training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Existence of malnutrition based on Z-Score (underweight and / or short stature), completing the consent form by parents, not using drugs or growth supplements in the last 6 months and announcing readiness not to use drugs in It was while studying.
Exclusion criteria: If during this period the child became ill, began to take any medication or supplement, the use of egg white protein powder was not done according to the required amount, or the parents or the child is reluctant They did not continue to study.
Intervention groups
Intervention group: Calculate the amount of egg white protein required for each child based on current weight and at a rate of 1 gram per kilogram of body weight and a pack of egg white protein powder with the necessary training
Main outcome variables
Investigation of anthropometric indictor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100223003408N9
Registration date:2021-03-10, 1399/12/20
Registration timing:prospective
Last update:2021-03-10, 1399/12/20
Update count:0
Registration date
2021-03-10, 1399/12/20
Registrant information
Name
Maryam Ekramzadeh
Name of organization / entity
Shiraz University of Medical Sciences, Nutrition Department
Country
Iran (Islamic Republic of)
Phone
+98 917 317 3891
Email address
ekramzadeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of egg white powder on anthropometric indices in malnourished children
Public title
The effect of egg white powder on the control of malnutrition in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Study of malnutrition based on Z-Score (underweight and / or short stature)
Completion of consent form by parents
Do not use growth medications or supplements for the past 6 months
Declare readiness not to use medications while studying
Exclusion criteria:
If during this period the child become ill
He start taking any kind of medicine or supplement
The use of egg white protein powder is not done according to the required amount
The parent or child is reluctant to continue the study
Age
From 3 years old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-03-21, 1396/01/01
Ethics committee reference number
IR.SUMS.REC.1396.162
Health conditions studied
1
Description of health condition studied
sever malnutrition
ICD-10 code
E41
ICD-10 code description
Nutritional marasmus
2
Description of health condition studied
moderate malnutrition
ICD-10 code
E44.0
ICD-10 code description
Moderate protein-calorie malnutrition
Primary outcomes
1
Description
weight
Timepoint
At the beginning of the study (before the intervention) and six weeks after the intervention
Method of measurement
scale
Secondary outcomes
1
Description
(Weight F hight z score)
Timepoint
At the beginning of the study (before the intervention) and six weeks after the intervention
Method of measurement
formula
2
Description
hight
Timepoint
At the beginning of the study (before the intervention) and six weeks after the intervention
Method of measurement
meter
3
Description
BIA
Timepoint
At the beginning of the study (before the intervention) and six weeks after the intervention
Method of measurement
Formula
4
Description
(Weight F age z score)
Timepoint
At the beginning of the study (before the intervention) and six weeks after the intervention
Method of measurement
Formula
5
Description
(Hight F age z score)
Timepoint
At the beginning of the study (before the intervention) and six weeks after the intervention
Method of measurement
Formula
6
Description
(BIA F age z score)
Timepoint
At the beginning of the study (before the intervention) and six weeks after the intervention
Method of measurement
Formula
Intervention groups
1
Description
Intervention group: The amount of egg white protein required for each child was calculated based on current weight and at a rate of 1 gram per kilogram of body weight and a packet of egg white protein powder with a special measure was given to parents. They were provided with the necessary training on how to use the powder, how to store it, along with a printed copy of the training, and were asked to include two or three servings of protein powder in yogurt, stews, soups, or other watery foods daily. (Provided it is not too hot) added and given to the child without notice. The study lasted for 6 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital
Full name of responsible person
Maryam Ekramzade
Street address
Gloshan Town
City
Shiraz
Province
Fars
Postal code
71876-56895
Phone
+98 71 3227 9701
Email
mekramzade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholam Reza Hatam
Street address
Zand Sreet
City
Shiraz
Province
Fars
Postal code
71876-56895
Phone
+98 71 3235 2559
Email
m_ekramzade@yahoo.com
Grant name
Shiraz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ekramzade
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
m_ekramzade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ekramzade
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi Blvd.
City
shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
m_ekramzade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Hamidianshirazi
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
mhamidian@sums.ac.ir
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