The effect of vitamin D on insulin resistance in renal failure patients
Design
Clinical trials with community-based and pragmatic control group, with parallel groups, not blindEd, randomized
Settings and conduct
A study with a therapeutic field in Ali ibn Abi Talib Hospital in Zahedan, Iran, is being conducted as a clinical trial.
Participants/Inclusion and exclusion criteria
No diabetes and impaired glucose metabolism; renal failure stages 2 to 4; vitamin D deficiency
Intervention groups
The intervention group included patients receiving vitamin D 5000 units weekly for up to 8 weeks for a period of three months; the control group included patients who did not receive any medication
Main outcome variables
Insulin resistance; Serum vitamin D levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170718035156N2
Registration date:2018-02-27, 1396/12/08
Registration timing:registered_while_recruiting
Last update:2018-02-27, 1396/12/08
Update count:0
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5799
Email address
dr.taheri@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D on insulin resistance in renal failure patients.
Public title
Effect of vit-D in renal failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No diabetes
renal failure stage 2 to 4
Exclusion criteria:
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block
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
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr.Hesabi Sq., Daneshgah Ave., Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2016-03-30, 1395/01/11
Ethics committee reference number
IR.ZAUMS.AC.IR.1395.150
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Renal failure
Primary outcomes
1
Description
Insulin resistance
Timepoint
Three months after treatment
Method of measurement
Based on the HOMA_IR formula
2
Description
Vitamin D level
Timepoint
Three months after treatment
Method of measurement
Luminescence electrochemical method
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group included patients receiving vitamin D 5000 units weekly for up to 8 weeks for a period of three months;
Category
Treatment - Drugs
2
Description
Control group: included patients who did not receive any medication