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

• Sponsor: Isfahan University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01278693
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Aug 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. lipid profile [at sixteen weeks after admission]

Secondary Outcome Measures

1. anemia [at sixteen weeks after admission]

2. quality of life [at sixteen weeks after admission]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Isfahan university of medical sciences

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01278693
• Other Study ID Numbers: ASD-1213-11
• First Posted: Jan 19, 2011
• Last Update Posted: Jan 19, 2011
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: Renal failure, hemodialysis, dyslipidemia, L-carnitine.
• Additional relevant MeSH terms: Dyslipidemias

Study Results

No Results Posted as of Jan 19, 2011