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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
  Purpose

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


Condition Intervention Phase
Complication of Hemodialysis
 Drug: L-carnitine
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Treatment of Dyslipidemia for Hemodialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • lipid profile [ Time Frame: at sixteen weeks after admission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 54
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Isfahan university of medical sciences  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: January 18, 2011
Last Updated: January 18, 2011
Health Authority: Iran: Ministry of Health

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

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Carnitine
Vitamin B Complex
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013