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Effect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients

Sponsor
Hormozgan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01305317
Collaborator
(none)
74
Enrollment
1
Location
1
Arm
36
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is double blind randomized controlled trial on the statins effects on serum IgG, IgA and IgM level in chronic hemodialysis patients in Bandarabbas

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study of Statins' Effect on Serum IgG, IgA Ang IgM Level in Chronic Hemodialysis Patients
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: lipitor

atorvastatin 20mg daily

Drug: Lipitor
Atorvastatin 20mg daily for 6 months
Other Names:
  • atorvastatin, statins

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum IgG, IgA and IgM level [6 months]

    Secondary Outcome Measures

    1. Drug side effects [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shahid Mohammadi hospital Bandar Abbas Hormozgan Iran, Islamic Republic of 79176

    Sponsors and Collaborators

    • Hormozgan University of Medical Sciences

    Investigators

    • Principal Investigator: Hamidreza Mahboobi, Hormozgan University of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01305317
    Other Study ID Numbers:
    • statins and Immunoglobulins
    First Posted:
    Feb 28, 2011
    Last Update Posted:
    Mar 1, 2011
    Last Verified:
    Jan 1, 2006
    Keywords provided by , ,
    Statin
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Atorvastatin

    Study Results

    No Results Posted as of Mar 1, 2011