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

NCT ID: NCT01278693

Last Updated: 2011-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Complication of Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

it is as like as L-carnitine in shape

Group Type OTHER

placebo

Intervention Type DRUG

500 mg,twice daily, 16 weeks.

L-carnitine

it is kind of supplement

Group Type OTHER

L-carnitine

Intervention Type DRUG

500 mg,twice daily, 16 weeks

Interventions

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L-carnitine

500 mg,twice daily, 16 weeks

Intervention Type DRUG

placebo

500 mg,twice daily, 16 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Isfahan University of Medical Sciences

Principal Investigators

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Mahnaz Moradi, MD

Role: STUDY_CHAIR

MD,research comittee

Locations

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Noor university hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

References

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Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.

Reference Type DERIVED
PMID: 36472884 (View on PubMed)

Other Identifiers

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ASD-1213-11

Identifier Type: -

Identifier Source: org_study_id

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