Evaluation of the effect of sodium valproate on albuminuria in type 2 diabetic patients through double-blind randomized clinical trial
Design
Clinical trial with control group, double-blind, randomized, phase 1-2 on 60 patients. For randomization, block randomization are used by randomization.com
Settings and conduct
This study is a double-blind randomized clinical trial that will be performed in the clinic of Shahid Motari and the clinic of Shahid Faghihi Hospital affiliated to Shiraz University of Medical Sciences.sodium valproate 200 mg of made by destin company daily in one group and twice a day in another group and also in the control group taking placebo.Valproic acid and placebo have exactly the same packaging and the patient and the prescribing physician will not know the type of prescription drug and only the analyzer is aware of the type of drug used by the patient according to the pre-written codes on the drug.
Participants/Inclusion and exclusion criteria
Entry requirements :Type 2 diabetic patients with microalbuminuria of more than 30 milligram in deciliter with an eGFR of more than 60 milliliter in a minute for 1.73 Square meters.
No entry conditions : disturbing factors that affect urinary protein excretion such as hypothyroidism or hyperthyroidism, uncontrolled hypertension or diabetes or history of allergy to sodium valproate
Intervention groups
Patients are divided into three groups to evaluate the effect of sodium valproate on albuminuria:
The control group that receives the placebo
The group that receives sodium valproate at a dose of 200 milligram per day.
The group that receives sodium valproate at a dose of 400 milligram per day.
Main outcome variables
level of microalbuminuria, glomerular filtration rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201023049126N1
Registration date:2021-03-30, 1400/01/10
Registration timing:registered_while_recruiting
Last update:2021-03-30, 1400/01/10
Update count:0
Registration date
2021-03-30, 1400/01/10
Registrant information
Name
Seyed Alireza Zomorodian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 5767
Email address
mil.zomorod@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assess the effectiveness of Sodium valproate on level of albuminuria in patient with type 2 diabetes :A double-blind randomized clinical trial
Public title
Sodium Valproate and Diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with DMTII
albuminuria more than 30mg/dl
Exclusion criteria:
Allergy to valproic acid
Significantly abnormal liver function test
A history of known mental disorders
History of cardiac or liver diseases
Females who were lactating, pregnant, or intending to become pregnant during the study.
A current history of alcohol addiction or drug abuse including analgesics
abnormal blood cells counts
eGFR less than 60 ml/min/1.73m2
hemoglobin A1c more than 8
Blood Pressure more than 160/100 mmHg
neurologic disease such as seizure
use antidepressant or antipsychotic drugs
History of GN, renal stone or other renal disease that induced proteinuria
active hematologic, rheumatologic or infectious diseases
active cancers or tumors
uncontrol hypo or hyper thyroidism
uncontrol hyper parathyroidism
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The people who enter the study with a block randomization method and using the randomization.com site 60 people are placed in a 20-item block .finally, Sixty people are assigned drugs in three ways.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using a placebo with the same shape, color, smell, taste, and box as sodium valproate, the patient becomes blind to the type of drug (placebo or drug).
The researcher who gives the drugs to the patients is not aware of the type of drug prescribed because the shape of the boxes is the same and only the code on the boxes is different. He/She does not aware of What do the codes mean and what kind of medicine does each code indicate.
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 Sciences
Street address
Administration Building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2021-01-02, 1399/10/13
Ethics committee reference number
IR.SUMS.REC.1399.1050
Health conditions studied
1
Description of health condition studied
diabetic nephropathy
ICD-10 code
E11.21
ICD-10 code description
Type 2 diabetes mellitus with diabetic nephropathy
Primary outcomes
1
Description
microalbuminuria
Timepoint
At the beginning of the study, one month, two months and three months after starting the drug
Method of measurement
Measurement of microalbuminuria of urine samples
Secondary outcomes
1
Description
liver function test
Timepoint
At the beginning of the study, one month, two months and three months after starting the drug
Method of measurement
Using the patient's blood sample
2
Description
complete blood count
Timepoint
At the beginning of the study, one month, two months and three months after starting the drug
Method of measurement
Using the patient's blood sample
Intervention groups
1
Description
Intervention group1:twenty patients take sodium valproate 200 mg tablet of Destin company daily for 3 months
Category
Treatment - Drugs
2
Description
Intervention group2: twenty patients take sodium valproate 200 mg of Destin company twice a day for 3 months
Category
Treatment - Drugs
3
Description
Control group1: Twenty patients take a placebo made by Shiraz School of Pharmacy daily for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari clinic
Full name of responsible person
Maryam Shafiee
Street address
Namazi sq, Shahid Motahari clinic
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
motahari@sums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Maryam Shafiee
Street address
Zand Street, shahid faghihi hospital
City
Shiraz
Province
Fars
Postal code
7194894596
Phone
+98 71 3235 1087
Email
Faghihi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeianzadeh
Street address
7th Floor, Administration Building of Shiraz University of Medical Sciences Zand St
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Alireza Zomorodian
Position
Medical Intern
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shiraz medical school, Emam Hosein sq, Zand st, Shiraz
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3208 4045
Email
mil.zomorod@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Shafiee
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Group Office, Namazi Medical Center, Namazi Square ,Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4316
Email
m_shafiee@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Alireza Zomorodian
Position
Medical Intern
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shiraz medical school, Emam Hosein sq, Zand st, Shiraz
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3208 4045
Email
mil.zomorod@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available