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Analyzing the effect of serum uric acid reduction using Allopurinol on vitamin D (25OHD) levels in hemodialysis patients

Protocol summary

Summary
The aim of this study is to analyze the correlation of serum uric acid and vitamin D in hemodialysis patients.This study is a clinical trial consisting of two steps. First we measure serum uric acid and 25OHD in patients under hemodialysis in the target hospitals. The main inclusion criteria are asymptomatic hyperuricemia and no vitamin D supplements in regimen.The main exclusion criterion is taking uric acid reducing agents before the study. We then devide the patients randomly into two groups of study and control. The study group will receive 100 mg Allopurinol tablets, daily for two months. The control group will receive placebo in the same period. After two months we will assess serum uric acid and vitamin D again. Data will be analyzed using SPSS software V.24 using coupled T and Chi square index.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015041721803N1
Registration date: 2017-05-28, 1396/03/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-28, 1396/03/07
Registrant information
Name
Negar Karevan
Name of organization / entity
Shahrekord university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 458 7409
Email address
st_karvan.n@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
The research center of Shahrekord University of Medical Sciences
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analyzing the effect of serum uric acid reduction using Allopurinol on vitamin D (25OHD) levels in hemodialysis patients
Public title
Analyzing the effect of serum uric acid reduction using Allopurinol on vitamin D levels in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hemodialysis patients; ESRD; Asymptomatic hyperuricemia; Exclusion criteria: Taking Uric acid reducting agents; Taking vitamin D supplements;
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Research department, Shahrekord University of Medical Sciences, Kashani blvd.
City
Shahrekord
Postal code
8815713471
Approval date
2016-12-19, 1395/09/29
Ethics committee reference number
IR.SKUMS.1395.231

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis; Dialysis (renal) NOS

Primary outcomes

1

Description
Vitamin D level
Timepoint
Before and after hyperuricemia treatment
Method of measurement
25OHD serum level immunoassey

Secondary outcomes

empty

Intervention groups

1

Description
Allopurinol tablet, 100 mg, daily for 60 days
Category
Treatment - Drugs

2

Description
Placebo tablet, daily for 60 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis wards in hospitals related to Shahrekord University of Medical Sciences
Full name of responsible person
Saeed Mardani MD
Street address
Hajar hospital, Parastar st, Shahrekord, Chaharmahal va Bakhtiari
City
Shahrekord, Farsan, Farrokhshahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research center of Shahrekord University of Medical Sciences
Full name of responsible person
Kamal Solati Phd
Street address
Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research center of Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Negar Karevan
Position
Medical student
Other areas of specialty/work
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Postal code
Phone
+98 38132220016
Fax
Email
st_Karevan.N@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Saeed Mardani MD
Position
Clinical Nephrologist
Other areas of specialty/work
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Postal code
Phone
+98 38132220016
Fax
Email
mardani_S@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Negar Karevan
Position
Medical student
Other areas of specialty/work
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Postal code
Phone
00
Fax
Email
st_karevan.n@skums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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