Effect of vitamin D supplementation on flow-mediated dilatation (FMD), Oxidized LDL (oxLDL) and Intracellular adhesion molecule 1 (ICAM1) in type 2 diabetic patients with hypertension.
Comparison of mean serum level of oxLDL, ICAM1and serum levels of vitamin D in the intervention and placebo groups before and after the intervention. Comparison of blood flow-mediated dilatation in the intervention and placebo groups before and after the intervention.
Hypertensive diabetic patients treated in the endocrinology clinic of Imam Khomeini Hospital. 48 of whom consented to participate in the study. At first general information were obtained. Individuals were coded into groups 1 and 2 using the Bias Coin method. Cans containing vitamin D and placebo capsules were coded 2 and 1 by Someone other than the researcher and provided to the researcher. Blood pressure, height, weight and BMI were measured. All patients completed sunlight questionnaire, 24-hour recall and MET physical activity questionnaire. Blood samples were taken to measure serum levels of vitamin D, ICAM1 and oxLDL. Ultrasonographic FMD evaluation was performed on the same day after a 15-minute horizontal rest and standard conditions.The intervention duration was 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 35 to 65 years old; at least 5 years diabetes history; similar and specific drugs.
Exclusion criteria: pregnancy and lactation; gastrointestinal diseases; any history of cardiovascular problem; endocrine diseases; malignancy; type 1 diabetes; BMI<4; drugs affecting vitamin D and calcium metabolism; insulin therapy and weight loss medications such as Orlistat.
Intervention groups
The intervention group (n = 23): one daily vitamin D capsule containing 2000 IU of cholecalciferol.
The placebo group (n = 21): placebo capsules containing lactose powder and magnesium stearate.
Main outcome variables
ICAM1; oxLDL; FMD; Vitamin D
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191223045861N1
Registration date:2020-01-27, 1398/11/07
Registration timing:retrospective
Last update:2020-01-27, 1398/11/07
Update count:0
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Reyhaneh Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3382 0985
Email address
ghasemi.sa@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
2019-02-16, 1397/11/27
Actual recruitment end date
2019-06-17, 1398/03/27
Trial completion date
2019-09-24, 1398/07/02
Scientific title
Effect of vitamin D supplementation on flow-mediated dilatation (FMD), Oxidized LDL (oxLDL) and Intracellular adhesion molecule 1 (ICAM1) in type 2 diabetic patients with hypertension.
Public title
Effect of vitamin D supplementation on type 2 diabetic patients with hypertension.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
At least 5 years diabetes history based on self-reported
Diabetes control with metformin, Glibenclamide, glitazone, Gliclazide or a combination of these
Blood pressure control with any of the Angiotensin receptor blockers (ARB), ACE Inhibitor, Calcium channel blockers (CCB), Thiazide diuretics or a combination of these
Exclusion criteria:
Pregnancy and lactation
Gastrointestinal diseases such as malabsorption
History of cardiovascular problems
Kidney، liver and other endocrine diseases
Malignancy
Type 1 diabetes
BMI<40
The consumption of vitamin D and multivitamin mineral supplements over the past 3 months
Drugs affecting vitamin D and calcium metabolism,
Insulin therapy
Weight loss medications such as Orlistat
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
46
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals were coded into groups 1 and 2 using the Bias Coin method
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals were coded into groups 1 and 2. Also Cans containing vitamin D and placebo capsules were coded 2 and 1 by someone other than the researcher and provided to the researcher in order to ensure that the researcher was not informed about the type of capsule consumed by each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Boostan dormitory, Zaker Ave., Apadana, Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Approval date
2019-01-16, 1397/10/26
Ethics committee reference number
IR.UMSU.REC.1397.404
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Flow-mediated dilatation changes
Timepoint
At baseline and week12
Method of measurement
Ultrasonography
2
Description
ICAM1
Timepoint
At baseline and week 12
Method of measurement
Serum level measurement using ELISA kit
3
Description
Oxidized LDL
Timepoint
At baseline and week 12
Method of measurement
Serum level measurement using ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1 vitamin D capsule daily containing 2000 IU of cholecalciferol manufactured by Nanohyat pharmaceutical company, Iran
Category
Treatment - Drugs
2
Description
Control group: 1 capsule daily containing lactose powder and magnesium stearate manufactured by Nanohyat pharmaceutical company, Iran
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ali Akbar Nasiri
Street address
Imam Khomeini Hospital, Ershad Ave., Modarres Blvd., Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
nasiriali7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Firooz Ghaderi Pakdel
Street address
Urmia University of medical science, Resalat Blvd., Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
fgpakdell@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Reyhaneh Ghasemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Boostan dormitory, Zaker Ave., Apadana Blvd., Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 44 3382 0985
Fax
Email
Ghasemi.sa@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reyhaneh Ghasemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Boostan dormitory, Zaker Ave., Apadana Blvd., Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 44 3382 0985
Fax
Email
Ghasemi.sa@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reyhaneh Ghasemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Boostan dormitory, Zaker Ave., Apadana Blvd., Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 44 3382 0985
Fax
Email
Ghasemi.sa@umsu.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