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Evaluation of vitamin D3 Supplementation on Serum Level of P-selectin and hs-CRP in Patients with Thrombosis, a Randimized Controled Trial

Protocol summary

Summary
Purpose: According to the latest published data, P-selectin, a tissue adhesion molecule is one of the most sensitive and the specific biomarkers for diagnosis of venous thromboembolism. In addition, data have indicated that there is a significant correlation between vitamin D3 deficiency and the incidence of thromboembolic events. This study was designed to examine the effect of vitamin D3 supplementation on serum levels of P-selectin. Methods: This was a mono-center, prospective, randomized controlled trial conducted in Tehran Heart Center, affiliated with Tehran Medical University. This study was approved in the ethic committee of university. All consented patients with 18 years old and over and with diagnosis of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) were recruited to this study and were randomized into two groups of intervention (n=20) and control(n=20). The exclusion criteria included the presence of any contraindications to use of vitamin D3, uncontrolled autoimmune and inflammatory diseases, pregnancy and any drugs, conditions and diseases that affect the P-selectin levels. Before supplementation of vitamin D3, serum levels of 25-hydroxy vitamin D3 and P-selectin and hs-CRP in each group were obtained. The intervention group was given a single intramuscular injection of 300,000 IU vitamin D3 but the control group was not given. After one month of follow up the serum levels of 25-hydroxy vitamin D3 and P-selectin and hs-CRP will obtain, analyze, and compare with pre-intervention levels.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112068307N1
Registration date: 2012-06-12, 1391/03/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-06-12, 1391/03/23
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-09, 1391/03/20
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin D3 Supplementation on Serum Level of P-selectin and hs-CRP in Patients with Thrombosis, a Randimized Controled Trial
Public title
Evaluation of vitamin D3 Supplementation on Serum Level of P-selectin and hs-CRP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusin criteria : patients with confirmed thrombosis up to 1 months; patients with 18 years old and over and consented patients. Exclusion criteria: hypercalcemia, nephrolithiasis,Sarcoidosis, vitamin D supplementation,malabsorbtion syndrome, Severe infection, uncontrolled autoimmune and inflammatory diseases and pregnancy and any drugs, conditions and diseases that affect the P-selectin levels.
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Updated, :
Secondary trial Id
Updated, :
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committe, Faculty of Pharmacy,Tehran University of Medical Sciences
Street address
16 Azar street
City
Tehran
Postal code
Approval date
2012-01-29, 1390/11/09
Ethics committee reference number
230/6858

2

Ethics committee
Name of ethics committee
Tehran Universty of Medical Sciences Ethics Committee
Street address
Updated, :
City
Tehran
Postal code
Approval date
2012-08-11, 1391/05/21
Ethics committee reference number
91-02-33-18319-62209

Health conditions studied

1

Description of health condition studied
Thrombosis
ICD-10 code
I82
ICD-10 code description
Other venous embolism and thrombosis

Primary outcomes

1

Description
p-selectin
Timepoint
before and 1 month after intervention
Method of measurement
ELAISA, lab

2

Description
hs-CRP
Timepoint
before and 1 month after intervention
Method of measurement
ELAISA, lab

Secondary outcomes

1

Description
25-hydroxy vitamin D3
Timepoint
before and 1 month after intervention
Method of measurement
Radioimmunoassay

Intervention groups

1

Description
Control group: is not given vitamin D 300000
Category
N/A

2

Description
Intervention: Ampule Vitamin D3 300,000 IU intramuscle every one month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancelor of reseasrch, TUMS
Full name of responsible person
Dr. Foutohi
Street address
Vice chancelor for reseasrch
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancelor of reseasrch, TUMS
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
TUMS
Full name of responsible person
Dr taher Entezari-Maleki
Position
Board of clinical Pharmacy specialty
Other areas of specialty/work
Street address
Faculty of Pharmacy, Department of Clinical Pharmacy.
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
tentezari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Taher Entezari-Maleki
Position
Faculty member
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
+98 21 6695 4709
Email
tentezari@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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