Back to results

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

Primary Purpose

Complication of Hemodialysis

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

L-carnitine

placebo

About this trial

This is an interventional treatment trial for Complication of Hemodialysis focused on measuring Renal failure, hemodialysis, dyslipidemia, L-carnitine.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Noor university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

placebo

L-carnitine

Arm Description

it is as like as L-carnitine in shape

it is kind of supplement

Outcomes

Primary Outcome Measures

lipid profile

Secondary Outcome Measures

anemia

quality of life

Full Information

NCT ID

NCT01278693

First Posted

January 18, 2011

Last Updated

January 18, 2011

Sponsor

Isfahan University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01278693

Brief Title

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

Official Title

Study of Treatment of Dyslipidemia for Hemodialysis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complication of Hemodialysis

Keywords

Renal failure, hemodialysis, dyslipidemia, L-carnitine.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Other

Arm Description

it is as like as L-carnitine in shape

Arm Title

L-carnitine

Arm Type

Other

Arm Description

it is kind of supplement

Intervention Type

Drug

Intervention Name(s)

L-carnitine

Intervention Description

500 mg,twice daily, 16 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

500 mg,twice daily, 16 weeks.

Primary Outcome Measure Information:

Title

lipid profile

Time Frame

at sixteen weeks after admission

Secondary Outcome Measure Information:

Title

anemia

Time Frame

at sixteen weeks after admission

Title

quality of life

Time Frame

at sixteen weeks after admission

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahnaz Moradi, MD

Organizational Affiliation

MD,research comittee

Official's Role

Study Chair

Facility Information:

Facility Name

Noor university hospital

City

Isfahan

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Links:

URL

http://www.mui.ac.ir

Description

Isfahan university of medical sciences

Learn more about this trial

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

We'll reach out to this number within 24 hrs