Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients
Study of Treatment of Dyslipidemia for Hemodialysis
1 other identifier
interventional
54
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 18, 2011
CompletedFirst Posted
Study publicly available on registry
January 19, 2011
CompletedJanuary 19, 2011
August 1, 2009
1.1 years
January 18, 2011
January 18, 2011
Conditions
Keywords
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
OTHERit is as like as L-carnitine in shape
L-carnitine
OTHERit is kind of supplement
Interventions
Eligibility Criteria
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
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.
PMID: 36472884DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mahnaz Moradi, MD
MD,research comittee
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