Effect of supplementation vitamin D3 on inflammatory and antioxidant factors in burnd patients
Design
A clinical trial with a control group with Two arms parallel-group randomized with Double blinding
Settings and conduct
In a double-blind controlled clinical trial study, 60 patients with 20% to 50% burn injuries referred to Imam Musa Kazem Medical Center and samples were randomly assigned to intervention and control groups.
At the beginning of the study and before the intervention, demographic information and history of previous diseases will be obtained using the prepared questionnaires, as well as test results, patients' paraclinical procedures, as well as anthropometric measurements and food intake information from patients, will be done.
This study is double-blind and the subjects will not know about the main supplement and placebo. Then, at the end of the study, fasting blood samples, anthropometric measurements, and nutritional information will be obtained from each patient again.
Participants/Inclusion and exclusion criteria
age range: 18-60, Patients with secondary degree burns with a burn level between 20-50%, Willing to participate in the study, not have a history of underlying diseases and other metabolic diseases, and not being pregnant or breastfeeding
Intervention groups
Pearl Vitamin D3 and Vitamin D3 placebo are designed for the control group.
Main outcome variables
Antioxidant markers, Inflammation markers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210116050044N1
Registration date:2021-03-08, 1399/12/18
Registration timing:registered_while_recruiting
Last update:2021-03-08, 1399/12/18
Update count:0
Registration date
2021-03-08, 1399/12/18
Registrant information
Name
Fahimeh Beigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3345 7670
Email address
f.beigi@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on inflammation and antioxidant markers in the burned hospitalized patients
Public title
Effect of vitamin D in treatment of burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
people between the ages of 18-60
patients with secondary degree burns with a burn level between 20%-50%
Vitamin D <30 ng/ml
lack of supplementation vitamin D during the last three months
No history underlying diseases including Kidney, Diabetes, hyperthyroidism and other metabolic diseases
No pregnancy and breastfeeding
Exclusion criteria:
lack of cooperation participators with project facilitators during this study
diagnosis of another chronic disease during this study
Each patient can be excluded from the study at any stage if he/she is not satisfied with the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, for random allocation, we used biased coin
the method in individual randomization unit by a coin toss, and
each person who was eligible for the study with flipping a
coin divided into intervention group if it was headed and
control group if it was tails
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, principle investigators, physicians, nurses who care for participants during the trial, data collectors were unaware of the control and intervention groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-11-11, 1399/08/21
Ethics committee reference number
IR.MUI.MED.REC.1399.950
Health conditions studied
1
Description of health condition studied
Burn of second degree of trunk, unspecified site
ICD-10 code
T21.20
ICD-10 code description
Burn of second degree of trunk, unspecified site
Primary outcomes
1
Description
The amount of vitamin D through ELISA test is measured in ng/l
Timepoint
Measurement of vitamin D will be at the beginning of the study (before the intervention) and after the intervention
Method of measurement
The measure of variable is done by ELISA method.
Secondary outcomes
1
Description
Inflammatory factor CRP is measured by photometric enriched turbidolatex method.
Timepoint
The variable is measured at the beginning of the study (before the intervention) and after the intervention at the end of the study.
Method of measurement
The measurement is done based on the CRP vial
2
Description
Antioxidant factors are measured in terms of ng / L based on ELISA method.
Timepoint
The variable is measured at the beginning of the study (before the intervention) and after the intervention at the end of the study.
Method of measurement
The method of measuring antioxidant factors by ELISA kit.
Intervention groups
1
Description
Intervention group: Vitamin D3 is produced in the form of a tablet with a dose of 2000 international units by Darsa Daru Pharmaceutical Company and is recommended for 8 weeks a day (one) at the same time with fatty foods.
Category
Treatment - Drugs
2
Description
Control group: vitamin D placebo is in the form of a pill with a dose of 2000 international units. To prepare a placebo, paraffin from Zahravi Pharmaceutical Company has been used and a placebo is recommended for 8 weeks a day (one) at the same time with the consumption of fatty foods.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan university of medical sciences
Full name of responsible person
Fahimeh Beigi
Street address
Hezar jrib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
f.beigi@mail.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice-Chancellery for Research and Technology university
Street address
Hezar jrib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
f.beigi@mail.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh Beigi
Position
Research expert
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Hezar jrib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
f.beigi@mail.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir mansoor Alavi
Position
PhD in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
009831036680048
Email
f.beigi@mail.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh Beigi
Position
Research expert
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Hezar jerib street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
f.beigi@mail.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of patient documents based on ethics in research
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
The effect of vitamin D supplementation on inflammation and antioxidant markers in the burned hospitalized patients. One of the most common deficiencies in the general population is vitamin D deficiency. This deficiency was present in more than 76% of critically ill patients, including burn patients.
When the data will become available and for how long
The data will become available on 1400/02/30 and the time of study takes three months.
To whom data/document is available
principle investigators, Co-workers, manuscript writers and research expert
Under which criteria data/document could be used
In order to scientific resources and under the conditions of citations
From where data/document is obtainable
comprehensive libarary system of medical university of Isfahan
What processes are involved for a request to access data/document
by researching of comprehensive libarary system of medical university of Isfahan