To examine the effect of vitamin D supplementation on type 2 diabetic patients with prior diagnosis of D hypovitaminosis, this randomized placebo controlled clinical trial is desigened. Participants would be randomized into two groups (recieving 50000 IU vitamin D or placebo) for eight weeks. Biochemical and anthropometric indices would be assessd before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707252480N8
Registration date:2017-10-13, 1396/07/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-13, 1396/07/21
Registrant information
Name
Mohammad Hassan Eftekhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
eftekharim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
No funding.
Expected recruitment start date
2017-01-10, 1395/10/21
Expected recruitment end date
2017-07-10, 1396/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation in overweight and obese people with type 2 diabetes and lipid disorders, and vitamin D deficiency
Public title
Vitamin D supplementation in dibetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for entering the study:
Willingness to participate; Prior diagnosis of type 2 diabetes by a specialist; Minimum duration of 2 years diagnosis; No Smoking or Drug abuse; No weight changes over the past 6 months (based on self report); The fixed type and dose of medications used in the last 6 months; Not having severe heart disease, stroke, liver disease, kidney, gastrointestinal, thyroid and parathyroid, rheumatoid arthritis and infectious diseases; Not using any supplements whether containing vitamin D and calcium or anti-oxidant supplements in the last 6 months; Absence of pregnancy or lactation
Exit criteria:
Misdiagnosis of demographic or anthropometric information; Failure to follow the design of the study (consuming less than 90% of supplements or not taking supplements for more than three consecutive periods); Unusual biochemical specimen; Use of any supplements other than the supplement provided in the study; Use of Venostat (orlistat)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University Of Medical Science
Street address
Zand Street, opposite of Palestine Street, The headquarters of Shiraz
City
Shiraz
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
ir.sums.rec.1396.22
Health conditions studied
1
Description of health condition studied
Diabetic patients with Vitamin D Defficiency
ICD-10 code
E10.9,E55.
ICD-10 code description
diabetes (mellitus)(nonobese)(obese),Vitamin D deficiency, unspecified
Primary outcomes
1
Description
TG
Timepoint
before and after 8 weeks of intervention
Method of measurement
Standard Enzymatic Method
Secondary outcomes
1
Description
Fbs
Timepoint
before and after 8 weeks of intervention
Method of measurement
Standard Enzymatic Method
2
Description
Serum vitamin D level
Timepoint
before and after 8 weeks of intervention
Method of measurement
Standard Enzymatic Method
3
Description
Net Weight Changes
Timepoint
before and after 8 weeks of intervention
Method of measurement
Scales
4
Description
waist circumference changes
Timepoint
before and after 8 weeks of intervention
Method of measurement
By flexible stata meter (at highest level of circumference)
5
Description
Glycated Hemoglubin
Timepoint
before and after 8 weeks of intervention
Method of measurement
Via standard labratory method (RIA)
6
Description
TG
Timepoint
before and after 8 weeks of intervention
Method of measurement
Standard Enzymatic Method
7
Description
TC
Timepoint
before and after 8 weeks of intervention
Method of measurement
Standard Enzymatic Method
8
Description
LDL
Timepoint
before and after 8 weeks of intervention
Method of measurement
Standard Enzymatic Method
9
Description
HDL
Timepoint
before and after 8 weeks of intervention
Method of measurement
Standard Enzymatic Method
10
Description
MAD
Timepoint
before and after 8 weeks of intervention
Method of measurement
Standard Enzymatic Method
11
Description
hsCRP
Timepoint
before and after 8 weeks of intervention
Method of measurement
ELISA kit
Intervention groups
1
Description
"Intervention group': Vitamin D supplementation(50000 IU/Week)
Category
Treatment - Drugs
2
Description
"Control group": placebo (1 capsule of corn oil same in shape, weight, color, and size with intervention supplement weekly)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Health Care Center
Full name of responsible person
Sahar Shahriari
Street address
Namazi Square
City
Shirazz
2
Recruitment center
Name of recruitment center
Faghihi health care center
Full name of responsible person
Sahar Shahriari
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Office Of Research and Technology ,Central Building Shiraz University Of O Medical Science, Street Zand
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University Of Medical Science
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
Departman of Clinical Nutrition, School of Nutrionand Food sciences, Shiraz university of medical Sc
Full name of responsible person
Sahar Shahriari
Position
Master Of Science In Nutrition
Other areas of specialty/work
Street address
Razi blvd,Department of Nutrition and Food Science
City
Shiraz
Postal code
Phone
+98 71 3725 1005
Fax
Email
saharshahriari42@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Depertman of Clinical Nutrition, School of Nutrition and food sciences, Shiraz university of medical
Full name of responsible person
Dr M.Hasan Eftekhari
Position
PhD,nutritional sci-Professor
Other areas of specialty/work
Street address
Razi blvd,Department Of Nutrition and Food Science
City
Shiraz
Postal code
Phone
+98 71 3725 1005
Fax
Email
h_eftekhari@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Departman of Clinical Nutrition, School of Nutrionand Food sciences, Shiraz university of medical Sc
Full name of responsible person
Sahar Shahrari
Position
Master Of Science in Nutrition
Other areas of specialty/work
Street address
Razi blvd.Department of Of Nutrition and Food Science
City
Shiraz
Postal code
Phone
+98 71 3725 1005
Fax
Email
saharshahriari42@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)