ِDetermining the effect of consuming pasteurized cow's milk fortified with albumin in underweight primary school children in Yasuj.
Design
A clinical trial with the control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. The software was used for randomization
Settings and conduct
Participants will be selected by two-stage random sampling from the list of all primary schools in Yasuj city, Iran. In this way, first, a list of all primary schools in Yasuj will be prepared, and after making the relevant arrangements with the school principal, the parents of the students will be contacted. For all students whose parents have given their final consent, the anthropometric parameters (height and weight) will be measured and entered into the Anthro WHO software to calculate the standard score (Z score). According to the definition of the World Health Organization, -3<= z-score<=-1) was considered as mild to moderate underweight. This stage will continue until the number of eligible children reaches 60.
Participants/Inclusion and exclusion criteria
Elementary students, lack of underlying disease affecting student development, do not take any dietary supplements or do not follow a special diet for 6 months before the study, mild to moderate underweight
Intervention groups
Participants in the intervention group receive 200 cc cow's milk with 10gr albumin powder per day and in the control group receive 200 cc cow's milk with 10gr cornstarch powder per day for 12 weeks.
Evaluating the effect of albumin consumption on malnutrition indices in primary school children with mild to moderate underweight
Public title
Albumin protein and malnutrition indices in primary school children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elementary students
Lack of underlying disease affecting student development such as diabetes, hypothyroidism, liver and kidney problems
Do not take dietary supplements or do not follow a special diet for at least 6 months before the study
Mild to moderate underweight
Exclusion criteria:
Age
From 7 years old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will randomly be allocated in a 1:1 ratio, to intervention and control groups. Randomization will be conducted by random allocation software to allocate patients using blocked randomization with a fixed block size of 4. Randomization will be done by an investigator who had no clinical involvement in the trial. Furthermore, other procedures including enrollment, sequence generation, allocation concealment, and randomization process will all be performed by the principal investigators.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind patients, the interventions in both groups will identical in appearance and color. The interventions will be coded differently in each group to blind the investigator.
Placebo
Used
Assignment
Parallel
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
Zand Blvd
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.SUMS.REC.1399.483
Health conditions studied
1
Description of health condition studied
Primary school children with mild to moderate underweight
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Z-Score Body mass index-for-age
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Anthropometric indicators through scales and tape meters; Body composition with BIA device.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in this group receive 200 cc cow's milk with 10gr albumin powder per day for 12 weeks
Category
Treatment - Other
2
Description
Control group: Participants in this group receive 200 cc cow's milk with 10gr cornstarch powder per day for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Primary schools in Yasuj city
Full name of responsible person
Hajar Davarpanah
Street address
Abshaar Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
0
Phone
+98 71 3612 2283
Email
davarpanah.nut65@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Siavash Babajafari
Street address
Razi Blvd
City
Shiraz
Province
Fars
Postal code
7193635889
Phone
+98 71 3612 2283
Email
jafaris@sums.ac.ir
Grant name
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
Siavash Babajafari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi Blvd
City
Shiraz
Province
Fars
Postal code
7193635889
Phone
+98 71 3612 2283
Email
jafaris@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Davarpanah
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Razi Blvd
City
Shiraz
Province
Fars
Postal code
7193635889
Phone
+98 71 3612 2283
Email
davarpanah.nut65@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Davarpanah
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Razi Blvd
City
Shiraz
Province
Fars
Postal code
7193635889
Phone
+98 71 3612 2283
Email
davarpanah.nut65@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data after unidentifiable individuals by the researcher is shareable
When the data will become available and for how long
The access period starts 6 months after publishing the results.
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to investigate and perform further analyzes
From where data/document is obtainable
Siavash Babajafari
09177871387
What processes are involved for a request to access data/document
After sending the request and reviewing the request by the coresponding author, the data will be provided to you