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

Complication of Hemodialysis Clinical Trial

Official title:

Study of Treatment of Dyslipidemia for Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278693
• Other study ID #: ASD-1213-11
• 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

• Complication of Hemodialysis

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

External Links

•   Isfahan university of medical sciences