NCT01278693

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
Last Updated

January 19, 2011

Status Verified

August 1, 2009

Enrollment Period

1.1 years

First QC Date

January 18, 2011

Last Update Submit

January 18, 2011

Conditions

Keywords

Renal failure, hemodialysis, dyslipidemia, L-carnitine.

Outcome Measures

Primary Outcomes (1)

  • lipid profile

    at sixteen weeks after admission

Secondary Outcomes (2)

  • anemia

    at sixteen weeks after admission

  • quality of life

    at sixteen weeks after admission

Study Arms (2)

placebo

OTHER

it is as like as L-carnitine in shape

Drug: placebo

L-carnitine

OTHER

it is kind of supplement

Drug: L-carnitine

Interventions

500 mg,twice daily, 16 weeks

L-carnitine

500 mg,twice daily, 16 weeks.

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noor university hospital

Isfahan, Isfahan, Iran

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Renal InsufficiencyDyslipidemias

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Mahnaz Moradi, MD

    MD,research comittee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

August 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 19, 2011

Record last verified: 2009-08

Locations