Evaluation of the effect of vitamin D3 supplementation in doses of 1000 and 3000 IU / day on hyperglycemic control, wound healing,wound infection and sepsis incidence and length of stay in hospital in burn patients
Evaluation of the effect of vitamin D3 supplementation in doses of 1000 and 3000 IU / day on hyperglycemic control, wound healing,wound infection and sepsis incidence and length of stay in hospital in burn patients
Design
Clinical trial with control group, blind, randomized, phase three on 54 patients. The crash was done using the computer software https://www.sealedenvelope.com.
Settings and conduct
With the cooperation of Ayatollah Taleghani Trauma and Burn Hospital in Ahvaz, the patients studied are selected from hospitalized in the age group of 18-50 years and from both sexes with a burn rate of 20-50%. On the one hand, it is done blindly, and the patients are those who are blind.
Participants/Inclusion and exclusion criteria
Age group 50-18 years
_ Burns 50-20%
- Second and third degree burns
- At least two weeks in the hospital according to the doctor's prognosis
Satisfaction of the individual
Absence of chronic diseases such as diabetes and high blood pressure and chronic kidney disease
No supplement with Vit D in the last 6 months
Lack of disorders such as hypoparathyroidism, hyperthyroidism, tumors and bone disease
Not receiving sex hormones to treat osteoporosis
- Patient awareness and ability to answer questionnaire questions
- Able to receive oral vitamin
Intervention groups
Group one: Receive a dose of 1000IU / day VitD3
Group Two: Receive a dose of 3000IU / day VitD3
Group three: Control group without supplement
Main outcome variables
Hyperglycemic control, wound healing, wound infection and sepsis, length of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200420047141N1
Registration date:2020-04-24, 1399/02/05
Registration timing:registered_while_recruiting
Last update:2020-04-24, 1399/02/05
Update count:0
Registration date
2020-04-24, 1399/02/05
Registrant information
Name
elaheh ghadimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 1272
Email address
ghadimi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-23, 1399/02/04
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin D3 supplementation in doses of 1000 and 3000 IU / day on hyperglycemic control, wound healing,wound infection and sepsis incidence and length of stay in hospital in burn patients
Public title
Evaluation of the effect of vitamin D3 supplementation in doses of 1000 and 3000 IU / day on hyperglycemic control, wound healing,wound infection and sepsis incidence and length of stay in hospital in burn patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 50_18 years
Burns 50-20%
Second and third degree burns
At least two weeks in the hospital according to the doctor's prognosis
Satisfaction of the individual
Absence of chronic diseases such as diabetes and high blood pressure and chronic kidney disease
No supplement with Vit D in the last 6 months
Lack of disorders such as hypoparathyroidism, hyperthyroidism, tumors and bone disease
Not receiving sex hormones to treat osteoporosis
Patient awareness and ability to answer questionnaire questions
Able to receive oral vitamin
Exclusion criteria:
Diagnosis of the relevant physician and discretion to discontinue the supplement due to clinical problems created in the patient
The patient's reluctance to continue studying
Reduce awareness and ability to answer questionnaire questions
The patient's death
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Https://www.sealedenvelope.com was used to randomly enter study participants. With the help of this site, for 54 participants in three defined groups A (group receiving 3000 IU of vitamin D daily), B (group receiving 1000 IU of vitamin D daily) and C (control group), the random order of entry in the study was determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants enter the study with a personal satisfaction form and all study cases are explained to them. However, he does not know in which group and for what purpose he entered. Before starting the study, the patient will be told that he or she will not be provided with any information.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jundishapur university of Medical Sciences
Street address
Golestan street, Arian1 building
City
Ahvaz
Province
Khouzestan
Postal code
6136753591
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.AJUMS.REC.1398.907
Health conditions studied
1
Description of health condition studied
Burn patients
ICD-10 code
T30-2, T30
ICD-10 code description
Burn of second degree, body region unspecified, Burn of third degree, body region unspecified
Primary outcomes
1
Description
Hyperglycemic control
Timepoint
At least twice a week
Method of measurement
Blood sampling in fasting mode
2
Description
Wound healing
Timepoint
Before the start of the intervention, 7 days and 14 days after the intervention
Method of measurement
Bates-jensenWound assessment tool
3
Description
Infection of the wound and sepsis
Timepoint
On the fifth day of hospitalization
Method of measurement
Biopsy of wound depth and blood culture
4
Description
The length of hospitalisation
Timepoint
From admission to discharge
Method of measurement
Count the number hospitalisation days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The first group receives a dose of 1000IU vitamin D from Flexan on a daily basis and orally from the time of admission until discharge from the hospital.
Category
Prevention
2
Description
Intervention group: The second group receives a dose of 3000IU vitamin D from Flexan on a daily basis and orally from the time of admission until discharge from the hospital. (To access this dose, each patient will receive a 1000IU perl and a 2000IU perl per day.)
Category
Prevention
3
Description
Control group: No supplements
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Trauma and Burn Hospital, Ahvaz
Full name of responsible person
Dr. Peyman Nejati
Street address
Khuozestan, Ahvaz, Padadshahr, The end of Hijrat Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3554 7996
Email
P.nejati97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Science, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 5975
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Elaheh Ghadimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Gulestan, Arian1 Building
City
Ahvaz
Province
Khouzestan
Postal code
6136753591
Phone
+98 61 3337 1272
Email
ghadimi.elaheh1996@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Anahita Mansoori
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Ahvaz Jundishapur University of Medical Science, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
mansoori-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Elaheh Ghadimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan, Arian1 Building
City
Ahvaz
Province
Khouzestan
Postal code
6136753591
Phone
+98 61 3337 1272
Email
ghadimi.elaheh1996@gmail.com
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
Due to the financial support of this research project carried out by Ahwaz Jundishapur University of Medical Sciences, it will be allowed to publish study data in the form of an article after the end of the intervention.