Evaluation of the effect of calcitriol supplementation on glucose, insulin, hemoglobin A1C, lipid profile and oxidative stress markers in hyperlipidemic patients with type 2 diabetes mellitus, Shiraz, 2009
To evaluate the effect of calcitriol supplementation on diabetes control and its complications in hyperlipidemic patients with type 2 diabetes mellitus 70 diabetic patients with age>30 years, Hb.A1C<8%, FBS<160 mg/dl, Serum Calcium < 10.5 mg/dl, LDL<150 mg/dl were recruited from Shahid Motahari clinic in Shiraz, Iran. They were randomly divided into 2 groups based on block randomization protocol: treatment group received 0.5 mcg calcitriol per day and control group received placebo. They were followed for 3 months. At weeks 0, 6 and 12 from the start of the study, fasting blood samples were taken.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806282480N1
Registration date:2010-05-08, 1389/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-08, 1389/02/18
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
Shiraz University of Medical Sciences
Expected recruitment start date
2009-08-01, 1388/05/10
Expected recruitment end date
2009-12-31, 1388/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of calcitriol supplementation on glucose, insulin, hemoglobin A1C, lipid profile and oxidative stress markers in hyperlipidemic patients with type 2 diabetes mellitus, Shiraz, 2009
Public title
Evaluation of the effect of calcitriol supplementation on diabetes control and its complications in hyperlipidemic patients with type 2 diabetes mellitus, Shiraz, 2009
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age>30 years, Hb.A1C<8%, FBS<160 mg/dl, Serum Calcium < 10.5 mg/dl, LDL<150 mg/dl, normal liver and kidney function, no history of kidney stone, not taking insulin therapy, no hypercalcemia was seen.
Exclusion criteria: using vitamin D supplement, pregnancy, smoking, UVB exposure with therapeutic goals, acute kidney or liver disease, hypercalcemia, hyperparathyroidism.
Age
From 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2009-08-03, 1388/05/12
Ethics committee reference number
88-4617
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
3 times, with 1.5 month intervals
Method of measurement
Auto analyser
2
Description
serum insulin
Timepoint
3 times, with 1.5 month intervals
Method of measurement
with Eliza kit, Monobind
Secondary outcomes
1
Description
Hb.A1C
Timepoint
before and after intervention
Method of measurement
Nycocard kit
2
Description
MDA (Malondialdehyde)
Timepoint
before and after intervention
Method of measurement
spectrophotometery
3
Description
lipid profile
Timepoint
3 times, with 1.5 month intervals
Method of measurement
auto analysor
4
Description
interleukin 1
Timepoint
2 times with 3 month intervals
Method of measurement
eliza kit
5
Description
interleukin 6
Timepoint
2 times with 3 month intervals
Method of measurement
eliza kit
6
Description
interleukin 18
Timepoint
2 times with 3 month intervals
Method of measurement
eliza kit
7
Description
CRP
Timepoint
2 times with 3 month intervals
Method of measurement
eliza kit
Intervention groups
1
Description
calcitriol intake, 0.5 mcg per day, for 3 months
Category
Treatment - Drugs
2
Description
placebo intake for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari clinic
Full name of responsible person
Street address
Shahid Motahari clinic
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Mohammad Hossein Dabaghmanesh
Street address
Shiraz university of medical sciences
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 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
School of health and nutrition, Shiraz University of Mediccal Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
MSc. student of nutrition
Other areas of specialty/work
Street address
Department of nutrition, School of health and nutrition, Shiraz University of Mediccal Sciences
City
Shiraz
Postal code
7153675541
Phone
+98 71 1725 1001
Fax
+98 71 1726 0225
Email
marzieh_akbarzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of health and nutrition, Shiraz University of Mediccal Sciences
Full name of responsible person
Dr. Mohammad Hassan Eftekhari
Position
PHD of nutrition, assistant professor of nutrition department
Other areas of specialty/work
Street address
Department of nutrition, School of health and nutrition, Shiraz University of Mediccal Sciences
City
Shiraz
Postal code
7153675541
Phone
+98 71 1725 1001
Fax
+98 71 1726 0225
Email
eftekharim@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Universoty of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
MSc student
Other areas of specialty/work
Street address
Shiraz, Shiraz Universoty of Medical Sciences, School of health and nutrition