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Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients

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ClinicalTrials.gov Identifier: NCT01278693
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
Isfahan University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Complication of Hemodialysis Drug: L-carnitine Drug: placebo Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of Treatment of Dyslipidemia for Hemodialysis
Study Start Date : August 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis
U.S. FDA Resources

Arm Intervention/treatment
placebo
it is as like as L-carnitine in shape
Drug: placebo
500 mg,twice daily, 16 weeks.
L-carnitine
it is kind of supplement
Drug: L-carnitine
500 mg,twice daily, 16 weeks



Primary Outcome Measures :
  1. lipid profile [ Time Frame: at sixteen weeks after admission ]

Secondary Outcome Measures :
  1. anemia [ Time Frame: at sixteen weeks after admission ]
  2. quality of life [ Time Frame: at sixteen weeks after admission ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278693


Locations
Iran, Islamic Republic of
Noor university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: Mahnaz Moradi, MD MD,research comittee

Additional Information:
Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01278693     History of Changes
Other Study ID Numbers: ASD-1213-11
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: August 2009

Keywords provided by Isfahan University of Medical Sciences:
Renal failure, hemodialysis, dyslipidemia, L-carnitine.