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Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis
Plain-language guide to NCT00173706: phase 4 non-randomized trial of L-Carnitine, anemia, 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00173706
- Phase
- phase 4
- Status
- status unknown
- Start
- 2004-10
- Completion (planned or actual)
- n/a
- Participants
- 40
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Cardiac Complications; Signs and Symptoms; Muscle Weakness; Anemia; Hypotension
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested L-Carnitine for anemia.
The registry classes the interventions as drug.
More on the Plan
L-Carnitine is a naturally occurring compound that facilitates the transport of fatty acids into mitochondria for beta-oxidation.
Who Took Part
The registry lists 40 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female adults over 18 years of age. On hemodialysis for at least one year. Bicarbonate dialysis 3 times per week. Modality of dialysis unchanged for 3 months prior to entry into the study (concerning dialysis-time and mode: bicarbonate, acetate dialysis). Persistent weakness affecting daily life.
The full record lists 14 inclusion and 16 exclusion criteria; among the exclusions: severe uncontrolled hypertension (systolic \> 170; diastolic \> 115) outside of dialysis; major hepatic diseases - chronic active (aggressive) hepatitis or cirrhosis; systemic haematological diseases and tumours.
How the Study Was Run
Design: non-randomized, single-group and open-label.
Being open-label, the L-Carnitine study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2004-10.
It ran at 1 site in Taiwan.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: weakness.
It also tracked 4 secondary outcomes, for example including all the components of the primary endpoints for their further assessment, intradialytic complications (muscle symptoms, dyspnea, palpitations) and quality of life.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of L-Carnitine in 40 people with anemia.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the L-Carnitine compound page, Anemia research.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.