investigation of the effectiveness of combination of losartan with Rocaltrol on treatment of albuminuria in patient with diabetic nephropathy; a clinical trial.
Diabetic nephropathy is the most common renal complication of diabetes. Previous study have reported the efficacy of Rocaltrol with Losartan on better treatment of diabetic nephropathy, although the role of vitamin D in reducing GFR and treatment of albuminuria is not clear. This study aim to evaluate the therapeutic effect of this combination strategy on Diabetic Nephropathy. In a double blind clinical trial phase 4, 132 diabetic nephropathy patients with aged 40 to 70 years old will be enrolled in the study. The exclusion criteria consist of patients with serum creatinine rising, K> 5.5 and with serum vitamin D deficiency. Then they investigate regarding lipid profile (HDL, LDL, TG, Cholesterol); Ca, P, HbA1C, Urine Albumin and Creatinine. The patients will be divided randomly into two case and control groups by simple sample method. The case group will received combination therapy with Losartan 25 mg/PO twice per day and Rocaltrol one capsule per day for 3 months and control group received Losartan 25 mg/PO twice per day for 3 months. The patient and the researchers are blind to the study. Afterwards, at the end of the study the ACR and other laboratory study will be repeated and the results of both groups will be compared with each other and statistically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110624903N1
Registration date:2015-11-29, 1394/09/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-29, 1394/09/08
Registrant information
Name
Mehdi Hadidi
Name of organization / entity
Arak University of Medical Sceince
Country
Iran (Islamic Republic of)
Phone
+98 912 759 8154
Email address
m.hadidi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-01-22, 1394/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation of the effectiveness of combination of losartan with Rocaltrol on treatment of albuminuria in patient with diabetic nephropathy; a clinical trial.
Public title
the effectiveness of Rocaltrol on treatment of albuminuria in pateint with diabetic nephropathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged between 40-70 years; diabetes mellitus type 2 that at least 3 months past diagnosis; Albuminuria is (urinary albumin >30 mg/24 hours); Signing Informed consent form; ca <9.5 and p <5.5; Not having an active urine analysis regarding Hematuria, pyuria and urine cast or crystal.
Exclusion criteria: K > 5.5 mg per deciliter or creatinine rising more than 30% after administration of Losartan; administration of vitamin D agents; acute infectious disease; acute heart failure; cancer; pregnancy; Urinary protein more than 8 gr/24 hours; vitamin D deficiency.
Age
From 40 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sceince
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Postal code
Approval date
2014-12-22, 1393/10/01
Ethics committee reference number
1196
Health conditions studied
1
Description of health condition studied
diabetic nephropathy
ICD-10 code
E11.2
ICD-10 code description
Non-insulin-dependent diabetes mellitus with renal complications
Primary outcomes
1
Description
HbA1C
Timepoint
3 month later
Method of measurement
labratory study
2
Description
Albumin to createnin ratio
Timepoint
3 month later
Method of measurement
labratory study
Secondary outcomes
1
Description
Ca
Timepoint
3 month later
Method of measurement
Labratory Study
2
Description
P
Timepoint
3 month later
Method of measurement
Labratory Study
Intervention groups
1
Description
case group :
Patients with diabetic nephropathy without vitamin D deficiency (66 patients) enroll to the study considering inclusion and exclusion criteria and they will be investigate regarding lipid profile (HDL, LDL, TG, Cholesterol); Ca, P, HbA1C, Urine Albumin and Creatinine, also the ACR ( Urine Albumin to creatinine ratio) will be calculated. They receive combination therapy with Losartan 25 mg/PO twice per day and Rocaltrol one capsule daily for 3 months. Afterwards, at the end of the study the laboratory study will be repeated and the results of both groups will be compared with each other and statistically analyzed.
Category
Treatment - Drugs
2
Description
Control group:
Patients with diabetic nephropathy without vitamin D deficiency (66 patients) enroll to the study considering inclusion and exclusion criteria and they will be investigate regarding lipid profile (HDL, LDL, TG, Cholesterol); Ca, P, HbA1C, Urine Albumin and Creatinine, also the ACR ( Urine Albumin to creatinine ratio) will be calculated. They receive Losartan 25 mg/PO twice per day for 3 months. Afterwards, at the end of the study the laboratory study will be repeated and the results of both groups will be compared with each other and statistically analyzed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
DR Mehdi Hadidi
Street address
Basij Sq., Amir Al Momenin Hospital.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammadreza Rezvanfar
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical sceinces
Full name of responsible person
Mehdi Hadidi
Position
Resident
Other areas of specialty/work
Street address
Basij Sq., Amir Al Momenin Hospital.
City
Arak
Postal code
Phone
+98 86 3417 3601
Fax
Email
dr_hadidy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sceinces
Full name of responsible person
Naser Saeidi
Position
Assistent professor
Other areas of specialty/work
Street address
Basij Sq., Amir al Momeini Hospital
City
Arak
Postal code
Phone
+98 86 3417 3601
Fax
+98 86 3417 3601
Email
rezvanfar@gmail.com, amiralmomenin@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sceinces
Full name of responsible person
Mehdi Hadidi
Position
Resident
Other areas of specialty/work
Street address
City
Arak
Postal code
Phone
+98 86 3417 3601
Fax
+98 86 3417 3601
Email
dr_hadidy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)