Comparison effect of two different doses of vitamin d injection supplements on foot ulcer status in type II diabetic patients with vitamin d deficiency
The objective of the present randomized controlled trial is to assess the effect of vitamin D injection on foot ulcer status in type 2 diabetic patients with vitamin d deficiency . At first foot ulcer was judged with the wager scale .Subjects with Wagner lower than 2 were included and their serum: D3, FBS , ESR ,WBC, CRP and foot scale were measured.50 Subjects assigned to 2 groups. group:A Received 300.000IU and group:B 150.000 IU vitamin D injection .After 4 week all tests were done to determine the effect of vitamin D injection on diabetic foot ulcer status in subjects have vitamin D
deficiency.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041321740N1
Registration date:2015-05-16, 1394/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Mohsen Haratian
Name of organization / entity
Shahid sadoughi university of medical sciences and health services
Country
Iran (Islamic Republic of)
Phone
+98 81 3622 2958
Email address
haratianmohsen@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences and Health Services
Expected recruitment start date
2015-03-17, 1393/12/26
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of two different doses of vitamin d injection supplements on foot ulcer status in type II diabetic patients with vitamin d deficiency
Public title
Effect of vitamin d injection supplements on foot ulcer status in type II diabetic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients with diabetic foot ulcers; Exclusion criteria: pregnancy; presence of associated autoimmune disease; use of anti convulsants (which alter the metabolism of vitamin D); concomitant osteomyelitis; low blood pressure; use of antibiotic in recently month; skin tumors on venous ulcers and/or lymphedema; ulcers in legs of other cause than venous insufficiency; patients with renal insufficiency; paresthesias of lower limbs and the need for surgical debridement.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Etihics-in-Research Commisson Shahid Sadoughi University of Medical Sciences and Health Services
Street address
Shahid Sadoughi University of Medical Sciences and Health Services, Institute for Reproductive Sciences, Bahonar Sq
City
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
پ/2702521/1/17
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E10, E11,
ICD-10 code description
Diabetic ulcer
Primary outcomes
1
Description
Foot ulcers scale patients
Timepoint
Before and after interventuon
Method of measurement
With Auto cad 2010
Secondary outcomes
1
Description
Serum 25(OH)D3
Timepoint
Before and after interventin(after 4 week)
Method of measurement
With kit ( ng/dl)
2
Description
FBS
Timepoint
Before and after interventin(after 4 week)
Method of measurement
With kit ( mg/dl)
3
Description
Serum CRP
Timepoint
Before and after interventin(after 4 week)
Method of measurement
With kit ( mg/l)
4
Description
Serum WBC
Timepoint
Before and after interventin(after 4 week)
Method of measurement
With kit ( micro/l)
5
Description
Serum ESR
Timepoint
Before and after interventin(after 4 week)
Method of measurement
With kit ( mm/hr)
Intervention groups
1
Description
GroupA: cure with 300000IU Vit D3
Category
Treatment - Drugs
2
Description
GroupB: cure with 150000IU Vit D3
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research center
Full name of responsible person
Mohsen Haratian
Street address
Hamedan Diabetes Research center, Emam Clinic, Mirzade Eshghi Street
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dr Mozaffari
Street address
Shahid Sadoughi University of Medical Sciences and Health Services, Health College
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences and Health Services
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
Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Mohsen Haratian
Position
Student in Nutrition
Other areas of specialty/work
Street address
Hamedan Diabetes Research center, Emam Clinic, Mirzade Eshghi street
City
Hamedan
Postal code
Phone
+98 81 3622 2958
Fax
+98 87221024
Email
Haratianmohsen@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services, Health College
Full name of responsible person
Dr Hassan Mozaffari khosravi
Position
Professor
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences and Health Services, Health College
City
Yazd
Postal code
Phone
+98 35 3724 3393
Fax
Email
Mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Mohsen Haratian
Position
Executive-Ms,c student in nutrition and health science
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Postal code
Phone
00
Fax
+98 87221024
Email
Haratianmohsen@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)