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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01278693
Other study ID # ASD-1213-11
Secondary ID
Status Completed
Phase Phase 2
First received January 18, 2011
Last updated January 18, 2011
Start date August 2009
Est. completion date September 2010

Study information

Verified date August 2009
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid profile, anemia, and quality of life.


Description:

In patients under maintenance hemodialysis several factors reduce the body stored carnitine which in turn affected dyslipidemia, anemia, and general health in these patients. The investigators evaluated the effect of oral L-carnitine supplementation on lipid profiles, anemia, and quality of life in hemodialysis patients.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

being in the age range of 18-75 having the history of at least 12 weeks of hemodialysis and at least three times a week and each session almost for four hours having serum triglyceride or total cholesterol concentration >200 mg/dl or serum HDL concentration >40 mg/dl in the beginning of the study.

Exclusion Criteria:

taking carnitine supplement or the drug that interact with carnation lowering the seizure threshold in the last month being affected by liver function abnormalities, hypothyroidism, chronic infectious diseases (such as hepatitis), inflammatory diseases, CNS mass having the history of seizure.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
L-carnitine
500 mg,twice daily, 16 weeks
placebo
500 mg,twice daily, 16 weeks.

Locations

Country Name City State
Iran, Islamic Republic of Noor university hospital Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary lipid profile at sixteen weeks after admission Yes
Secondary anemia at sixteen weeks after admission Yes
Secondary quality of life at sixteen weeks after admission Yes
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