Objective: This is a randomized, double-blinded, placebo-controlled phase 2 trial to prospectively test the effectiveness of oral vitamin d in reduction of proteinuria in patients with diabetic nephropathy and vitamin D deficiency.
Inclusion criteria: having type 2 diabetes; diabetic nephropathy; vitamin D deficiency; GFR> 60 and recieving stable doses of ACE inhibitors or ARBs for 3 months or more.
Exclusion criteria: glomerulonephritis; serum phosphorus level greater than 5.2 mg/dL; serum calcium level (adjusted for albumin) greater than 10.0 mg/dL; active malignancy;likelihood of requiring renal replacement therapy within 1 year or uncontrolled hypertension. Design and intervention: at enrollment, 50 patients with diabetic nephropathy and vitamin D deficiency, will be randomly assigned into 1 of 2 parallel groups: group A: 30 persons will enroll in the case group and treatment will be initiated with oral vitamin D( pearl 50000IU) one pearl every week for 12 week or group B: 30 patients will be received placebo, 1 pearl/ weekly for 12 week. After 12 weeks the patients, will be checked for 25-hydroxy vitamin D levels and the patient in placebo group will receive vitamin D. Patients were examined at baseline,12 weeks and at the end of the study.
Main outcomes: in every session UACR(urine albumin creatinin ratio) at first morning void will be assessed. The efficacy measure was the percentage change mean UACR from baseline to the last measurement during treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204049374N1
Registration date:2012-08-07, 1391/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-07, 1391/05/17
Registrant information
Name
Nooshin Ahmadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31166855555
Email address
nooshinahmadi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences and Isfahan Endocrine and Metabolism Research Center
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin D effect on reduction of proteinuria in patients with diabetic nephropathy and vitamin d deficiency
Public title
Vitamin D effect on reduction of proteinuria in patients with diabetic nephropathy and vitamin d deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having type 2 diabetes; diabetic nephropathy; vitamin D deficiency; GFR> 60 and recieving stable doses of ACE inhibitors or ARBs for 3 months or more.
Exclusion criteria: glomerulonephritis; serum phosphorus level greater than 5.2 mg/dL; serum calcium level (adjusted for albumin) greater than 10.0 mg/dL; active malignancy;likelihood of requiring renal replacement therapy within 1 year or uncontrolled hypertension.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Isfahan University of Medical Sciences Ethics Committee
Street address
hezar jerib street,Isfahan
City
Isfahan
Postal code
Approval date
2011-07-10, 1390/04/19
Ethics committee reference number
390287
Health conditions studied
1
Description of health condition studied
diabetic nephropathy
ICD-10 code
E11
ICD-10 code description
non insulin dependent diabet mellitus
Primary outcomes
1
Description
Urine albomin/ creatinin ratio
Timepoint
Before intervention and 3 and 6 months after intervention
Method of measurement
urine Alb/cr (mg/ gr)
Secondary outcomes
empty
Intervention groups
1
Description
intervention: vitamin D pearl; 50000 unit, once weekly to 12 weeks
Category
Treatment - Drugs
2
Description
control:placebo pearl, once weekly to 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolic Diseases Research Center
Full name of responsible person
Nooshin Ahmadi
Street address
Khoram street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for reaserch, Isfahan University of Medical Sciences
Full name of responsible person
Dr Azarm
Street address
Isfahan university of medical sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for reaserch, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Nooshin Ahmadi
Position
MD, Resident of internal medicine
Other areas of specialty/work
Street address
Hezar jerib street,Isfahan
City
Isfahan
Postal code
Phone
Fax
Email
nooshinahmadi@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Bijan Iraj
Position
Assistant professor/ endocrinologist
Other areas of specialty/work
Street address
Hezar jerib street, Isfahan
City
Isfahan
Postal code
Phone
Fax
Email
bijaniraj@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nooshin Ahmadi
Position
MD, Resident of internal medicine
Other areas of specialty/work
Street address
Hezar jerib street, Isfahan
City
Isfahan
Postal code
Phone
Fax
Email
nooshinahmadi@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)