Protocol summary

Summary
The aim of the study was to investigate the effects of simultaneous use of vitamin D and chromium picolinate on the markers of oxidative stress, inflammation, glucose, lipids and endothelial dysfunction in patients with type2. Inclusion criteria included patients with type 2 diabetes for up to 5 years with metformin as medicine and with age ranging from 25 to 65. Exclusion criteria included patients with insulin injections, inflammatory diseases, kidney disease, liver diseases, parathyroid disease, pregnancy and lactation, anticonvulsant and steroid use, history of smoking, use of supplements and minerals, hyper and hypothyroidism. The total sample size was 96 patients were divided in 4 groups of 24 people. The first group received placebo, the second group received chromium picolinate, the third group received vitamin and fourth group received chromium picolinate and vitamin D simultaneously for 6 months. It is expected that consumption of these supplements improves lipid, oxidative stress and inflammation patterns and endothelial dysfunction in these patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052034038N1
Registration date: 2017-06-14, 1396/03/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Fatemeh Imanparast
Name of organization / entity
Khomein University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 4622 6006
Email address
library.khomein@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Khomein University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Simultaneous use of chromium picolinate and vitamin D reconstruction or prevention of endothelial dysfunction in patients with type 2 diabetes by examining the pattern of changes in metabolic markers of oxidative stress, inflammation and endothelial dysfunction
Public title
Prevention of endothelial dysfunction in patients with type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
(Inclusion criteria: patients with type 2 diabetes for a maximum of 5 years; 25 to 60 years ages; with metformin as a hypoglycemic medication) (Exclusion criteria: patients with Insulin injection; inflammatory diseases; kidney disease; liver disease; parathyroid disease; pregnancy and lactation; taking anticonvulsants and steroids; history of tobacco; the use of supplements and minerals ; patients with hypertension and hypothyroidism)
Age
From 25 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Markazi Province university of Medical Sciences and Health Services,
Street address
Assistance Education and Research, On the campus of University of Medical Sciences, Basij square, Arak
City
Arak
Postal code
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
IR.ARAKMU.REC.1395.466

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
Before and after the intervention.
Method of measurement
KIT

2

Description
Oral glucose tolerance test
Timepoint
Before and after the intervention.
Method of measurement
KIT

3

Description
glycated haemoglobin (HbA1C)
Timepoint
Before and after the intervention.
Method of measurement
KIT

4

Description
Cholesterol of LDL
Timepoint
Before and after the intervention.
Method of measurement
KIT

5

Description
HDL-C
Timepoint
Before and after the intervention.
Method of measurement
KIT

6

Description
TRIGLYCERIDE
Timepoint
Before and after the intervention.
Method of measurement
KIT

7

Description
TOTAL CHOLESTROL
Timepoint
Before and after the intervention.
Method of measurement
KIT

8

Description
Tumor necrosis factor alpha (TNF-α)
Timepoint
Before and after the intervention.
Method of measurement
KIT

9

Description
Malondialdehyde (MDA)
Timepoint
Before and after the intervention.
Method of measurement
KIT

10

Description
Total thiols OF PROTIENS
Timepoint
Before and after the intervention.
Method of measurement
KIT

11

Description
the total antioxidant capacity
Timepoint
Before and after the intervention.
Method of measurement
KIT

12

Description
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
Timepoint
Before and after the intervention.
Method of measurement
KIT

13

Description
Plasminogen activator inhibitor type 1 (PAI-1)
Timepoint
Before and after the intervention.
Method of measurement
KIT

14

Description
INSULIN
Timepoint
Before and after the intervention.
Method of measurement
KIT

15

Description
CHROMIUM
Timepoint
Before and after the intervention.
Method of measurement
KIT

16

Description
25(OH) D3
Timepoint
Before and after the intervention.
Method of measurement
KIT

17

Description
CALCIUM
Timepoint
Before and after the intervention.
Method of measurement
KIT

18

Description
PHOSPHOR
Timepoint
Before and after the intervention.
Method of measurement
KIT

19

Description
parathyroid hormone test
Timepoint
Before and after the intervention.
Method of measurement
KIT

Secondary outcomes

empty

Intervention groups

1

Description
The second group: receiving 400 microgram of chromium picolinate daily for 6 months
Category
Treatment - Drugs

2

Description
The third group: receiving vitamin D for 6 months, per week 50,000 IU
Category
Treatment - Drugs

3

Description
the first group: the control group received a placebo for 6 months.
Category
Treatment - Drugs

4

Description
fourth Group : receiving Vitamin D and chromium picolinate for six months, 50,000 units per week and 400 micrograms for per day, respectively.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Javad javaheri
Street address
City
Khomein

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Imanparast
Street address
Khomein University of Medical Sciences, Quds Boulevard, Khomein
City
Khomein
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomein University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
dr.Fatemeh Imanparast
Position
Science Committee
Other areas of specialty/work
Street address
Khomein University of Medical Sciences, Quds Blvd, Khomien,
City
Khomein
Postal code
Phone
+98 86 4622 6006
Fax
Email
fimaniran64@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Dr.Fatemeh Imanparast
Position
Assistant Professor
Other areas of specialty/work
Street address
Khomein University of Medical Sciences, Quds Blvd, Khomien
City
Khomien
Postal code
Phone
+98 86 4622 6006
Fax
Email
FIMANIRAN64@GMAIL.COM
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Dr.Fatemeh Imanparast
Position
Science Committee
Other areas of specialty/work
Street address
Khomein University of Medical Sciences, Quds Boulevard, Khomien
City
Khomien
Postal code
Phone
+86 46226006
Fax
Email
fimaniran64@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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