The effect of vitamin D injection on tumor necrosis factor alpha (TNF) and vascular cell adhesion molecule 1 (SVCAM-1) in vitamin D deficient patients with Type 2 Diabeties
The aim of this study was to determine the effect of vitamin D injection supplement on tumor necrosis factor-alpha and the soluble form of vascular cell adhesion molecule 1 in patients with type 2 diabetes with vitamin D deficiency.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 1-2 was performed on 50 patients. Random computer-derived random codes (random allocation table) were used for randomization.
Settings and conduct
This study was performed on patients with diabetes, with vitamin D deficiency who refer to the Diabetes Center of Yazd city. The researcher and the patient were blinded. For hiding after randomization by random allocation table, we selected and numbered the sample volume of the envelope and then wrote the control and intervention group identification sheets based on the output of the table and put them in the envelope and then sealed the envelope to allocate medicine or We provided control to the secretary or medical staff.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-Diabetic patients and HbA1c less than 9 %.
2-25-hydroxy vitamin d serum level less than 20 ng per ml.
3-Aged 30-60.
Exclusion criteria: 1- Lack of interest in participating in study.
2-Use of vitamin D supplements during the last 3 months.
3-Kidney and liver diseases, malabsorption syndrome, severe infection.
4-Use of immunosuppressive drugs.
5-Pregnancy and lactation.
6-Use of insulin.
Intervention groups
The intervention group received an injectable vitamin D supplement at a dose of 400,000 IU in two injections (200,000 IU each time) and the control group did not receive any specific intervention.
Main outcome variables
Determination and comparison of mean serum levels of vitamin D, tumor necrosis factor-alpha and soluble form of vascular cell adhesion molecule -1 between and within the study groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200913048697N1
Registration date:2020-09-28, 1399/07/07
Registration timing:registered_while_recruiting
Last update:2020-09-28, 1399/07/07
Update count:0
Registration date
2020-09-28, 1399/07/07
Registrant information
Name
Siavash Babaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 8778
Email address
s.babaie86@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D injection on tumor necrosis factor alpha (TNF) and vascular cell adhesion molecule 1 (SVCAM-1) in vitamin D deficient patients with Type 2 Diabeties
Public title
Effect of vitamin d on inflammatory factors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having diabetes and HbA1c less than 9 percent
25-hydroxy vitamin d serum level less than 20 ng per milliliter
Aged 30-60
Exclusion criteria:
Lack of interest in participating in the study
Vitamin d supplement intake in last 3 month
Impaired absorption, liver and kidney diseases and severe infection
Immune system suppressor medication
Pregnancy and lactation
Insulin using
Age
From 30 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The 50 patients included in the study will be divided into intervention group with monthly vitamin D injection (25 subjects) and control group (25 subjects) using simple randomization and SPSS statistical software. Individuals will be randomly assigned to intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
For concealment after randomization by the random allocation table, we select and number the envelope sample size and then write the control and intervention group identification sheets based on the output of the table and then provide the sealed envelope for drug or control allocation for medical staff.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research School of Health - Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Yazd, Alam Square, Shohadaye Gomnam Boulevard, Medical Sciences Campus, Faculty of Health
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Approval date
2020-05-16, 1399/02/27
Ethics committee reference number
IR.SSU.SPH.REC.1399.041
Health conditions studied
1
Description of health condition studied
Diabetic patients with vitamin D deficiency.
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Tumor necrosis factor alpha.
Timepoint
before intervention, 2 month after intervention.
Method of measurement
Using laboratory kits for measuring the desired factors with ELISA technique.
2
Description
soluble vascular cell adhesion molecule 1
Timepoint
before intervention, 2 month after intervention.
Method of measurement
Using laboratory kits for measuring the desired factors with ELISA technique.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Doses of 200,000 international units of vitamin D were injected at the beginning and one month after the start of the study, a total of 400,000 international units.
Category
Prevention
2
Description
Control group: The control group does not receive anything.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research and Treatment Center
Full name of responsible person
Dr. Saeed Hossein Khalilzadeh
Street address
The end of Art Hall Alley,.Shahid Sadoughi BlVd ,. Bahonar Square towards Azadi Square,. Yazd.
City
Yazd
Province
Yazd
Postal code
7916978477
Phone
+98 35 3728 0226
Email
drc@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaie
Street address
University of Medical Science, Central Administration, Bahonar Square, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3146 2136
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?