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

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01278693
First received: January 18, 2011
Last updated: NA
Last verified: August 2009
History: No changes posted

January 18, 2011
January 18, 2011
August 2009
September 2010   (final data collection date for primary outcome measure)
lipid profile [ Time Frame: at sixteen weeks after admission ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • anemia [ Time Frame: at sixteen weeks after admission ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: at sixteen weeks after admission ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients
Study of Treatment of Dyslipidemia for Hemodialysis

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Complication of Hemodialysis
  • Drug: L-carnitine
    500 mg,twice daily, 16 weeks
  • Drug: placebo
    500 mg,twice daily, 16 weeks.
  • placebo
    it is as like as L-carnitine in shape
    Intervention: Drug: placebo
  • L-carnitine
    it is kind of supplement
    Intervention: Drug: L-carnitine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
September 2010
September 2010   (final data collection date for primary outcome measure)

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.

Female
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01278693
ASD-1213-11
Yes
Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Study Chair: Mahnaz Moradi, MD MD,research comittee
Isfahan University of Medical Sciences
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP