- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01305317
Effect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients
February 28, 2011 updated by: Hormozgan University of Medical Sciences
Study of Statins' Effect on Serum IgG, IgA Ang IgM Level in Chronic Hemodialysis Patients
This is double blind randomized controlled trial on the statins effects on serum IgG, IgA and IgM level in chronic hemodialysis patients in Bandarabbas
Study Overview
Detailed Description
This study is a randomized controlled trial of statins effect on serum IgG, IgA and IgM level on chronic hemodialysis patients in Bandarabbas.
The study is carried out in Hormozgan, Iran.
Seventy four patient were randomized either to receive atorvastatin in addition of usual treatment or not.
The primary outcomes were serum IgG,IgA and IgM level.
The secondary outcome was drug side effects.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hormozgan
-
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79176
- Shahid Mohammadi hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All chronic hemodialysis patients attending Shahid Mohammadi hospital during the study period
- Accepting to participate in the study
Exclusion Criteria:
- Refusing to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lipitor
atorvastatin 20mg daily
|
Atorvastatin 20mg daily for 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum IgG, IgA and IgM level
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drug side effects
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hamidreza Mahboobi, Hormozgan University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
February 25, 2011
First Submitted That Met QC Criteria
February 25, 2011
First Posted (Estimate)
February 28, 2011
Study Record Updates
Last Update Posted (Estimate)
March 1, 2011
Last Update Submitted That Met QC Criteria
February 28, 2011
Last Verified
January 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- statins and Immunoglobulins
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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