This study is a single blind, controlled clinical trial to determine the effect of Allopurinol on serum uric acid level and arterial blood pressure in hemodialysis patients with hypertension and hyperuricemia .The main inclusion criteria are mild,moderate or sever hypertension and hyperuricemia(greater than 7 and 6 in men and women respectively)and excluding criteria are irregular use of the drug and the development of sever side effects.The study population consist of 146 patients undergoing hemodialysis.The Patients are randomly divided into 2 groups.The first group will receive allopurinol As uric acid-lowering agent 100 mg daily for three months and the second group receive placebo as control for the same time.Then at the end of first, second and third months measurement of blood pressure and uric acid is done as the primary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120820243N1
Registration date:2015-01-03, 1393/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-03, 1393/10/13
Registrant information
Name
Seyed mohammad kazem Sadeghi
Name of organization / entity
Health Ministry
Country
Iran (Islamic Republic of)
Phone
+98 83 3421 3325
Email address
smk.sadeghi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of allopurinol on serum uric acid level and arterial blood pressure in hemodialysis patients
Public title
َAllopurinol prescription for better control of blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Hypertension؛ hyperuricemia؛ patients must be on dialysis since at least 3 month ago؛ no taking diuretics؛no taking other uric acid lowering agents؛have signed the informed consent. Exclusion criteria:irregular use of the drug؛presence of severe adverse effects
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah university of medical sceiences
Street address
Shahid Beheshti Blv
City
Kermanshah
Postal code
Approval date
2014-03-04, 1392/12/13
Ethics committee reference number
53868
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
112.0
ICD-10 code description
Hypertensive renal disease with renal failur
2
Description of health condition studied
hyperuricemia
ICD-10 code
E79.0
ICD-10 code description
Asymptomatic hyperuricaemia
Primary outcomes
1
Description
Blood pressure
Timepoint
before intervention,one and two and three months after begining
Method of measurement
by mercury barometer in scale of mm Hg
2
Description
uric acid
Timepoint
Before intervention 1,2 and 3 months later
Method of measurement
by blood sampling
Secondary outcomes
1
Description
the drug side effects
Timepoint
Before intervention 1,2 and 3 months later
Method of measurement
clinical manifestations and CBC
Intervention groups
1
Description
Intervention group:they get Allopurinpl 100 mg one tablet daily for three months with meal(lunch ordinner)
Category
Treatment - Drugs
2
Description
control:multivitamine one tablet daily for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imamreza Hospital
Full name of responsible person
Seyed Mohammadkazem sadeghi internal medicine resident
Street address
Imamreza Hospital Dialysis ward
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Mciences
Full name of responsible person
Hamzehee Koroush
Street address
Shahid Beheshti Street
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Mciences
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
Kermanshah University Of Medical Sciences
Full name of responsible person
Seyed Mohammad kazem Sadeghi
Position
Internal resident
Other areas of specialty/work
Street address
Kermanshah Imam reza Hospital Internal office
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
smk.sadeghi@kums.ac.ir smksadeghi9@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University Medical Sciences
Full name of responsible person
Hamidreza Omrani
Position
Nephrologist
Other areas of specialty/work
Street address
Imam reza hospital
City
Kermanshah
Postal code
Phone
+98 834276309
Fax
Email
hamidomrani@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Seyed Mohammad kazem Sadeghi
Position
Internal resident
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
smk.sadeghi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)