CARNITOR SUMMARY
CARNITOR® (levocarnitine) is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane.
For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.
For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. (US Patent Nos. 6,335,369; 6,429,230; 6,696,493)
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NEWS HIGHLIGHTS
Published Studies Related to Carnitor (Levocarnitine)
A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders. [2011.06] CONCLUSIONS: L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.
A prospective double-blind, randomized clinical trial of levocarnitine to treat
autism spectrum disorders. [2011] CONCLUSIONS: L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for
Levocarnitine administration in elderly subjects with rapid muscle fatigue: effect on body composition, lipid profile and fatigue. [2003] CONCLUSION: Administration of levocarnitine to healthy elderly subjects resulted in a reduction of total fat mass, an increase of total muscle mass, and appeared to exert a favourable effect on fatigue and serum lipids.
Double-blind parallel design pilot study of acetyl levocarnitine in patients with Alzheimer's disease. [1992.11] Acetyl levocarnitine hydrochloride has been reported to retard dementia in patients with Alzheimer's disease. In a double-blind, parallel design, placebo-controlled pilot study of 30 mild to moderately demented patients with probable Alzheimer's disease, tests of memory, attention, language, visuospatial, and constructional abilities were administered, and the level of acetyl levocarnitine was measured in the cerebrospinal fluid...
Clinical Trials Related to Carnitor (Levocarnitine)
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants [Recruiting]
Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early
growth which places them at increased risk for developmental problems later in life. The
micronutrient carnitine, which is present in breast milk and stored in the fetus late in
pregnancy, has been shown to protect against brain injury in animal studies. Without
supplementation, almost all preterm infants develop carnitine deficiency soon after birth.
Thus it is important to determine if carnitine supplementation protects against brain injury
and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that
preterm infants supplemented early with L-carnitine while receiving parenteral nutrition
will not develop carnitine deficiency and will have improved growth in the first two weeks
of life and higher scores on developmental tests when compared to control infants who did
not receive carnitine.
Effect of Carnitine Deficiency on Myocardial Function in Children Receiving Continuous Renal Replacement Therapy [Recruiting]
Carnitine is a nutrient that is usually obtained from the diet, and it is needed for
providing energy to the heart and the other muscles in the body. Carnitine is often given to
adults and children with kidney failure who receive chronic dialysis three times a week,
however there is no published information on how carnitine affects children receiving
continuous dialysis (CRRT). We hypothesize that children receiving CRRT quickly become
deficient in carnitine because it is continuously removed during dialysis. The aim of this
study to determine if giving daily carnitine to children on CRRT will help improve their
cardiac function, as assessed by echocardiography, in comparison to a control group.
Evaluation of Cilostazol in Combination With L-Carnitine [Completed]
The purpose of this study is to see how safe and effective L carnitine taken with cilostazol
is compared to placebo taken with cilostazol for people with intermittent claudication. A
second purpose of the study is to see if L-carnitine is absorbed into the blood stream.
Identification of Carnitine-Responsive Cardiomyopathy [Not yet recruiting]
There are some adults with skeletal muscle weakness (called "myopathy") and heart muscle
weakness (called "cardiomyopathy") who have low blood levels of a compound called carnitine
as a cause of their problems. Carnitine is very important to energy production in muscles.
In fact, there are reports of some people with carnitine deficiency who have developed
myopathy and cardiomyopathy that was completely reversed with carnitine treatment. The main
objective of our project is to determine the number of patients who have carnitine
deficiency as a cause of their myopathy and cardiomyopathy. The investigators will be
measuring carnitine levels in 1000 patients with cardiomyopathy and will describe the
specific features in all the study patients to see if there are any trends that may help us
predict which patients with muscle weakness are at risk of developing low carnitine levels.
The investigators will be treating patients with low carnitine levels with carnitine and
observing them to see if their cardiomyopathy and their muscle weakness improve. Knowing
the exact percentage of myopathy and cardiomyopathy patients with carnitine deficiency may
allow for screening of patients in a cheap and targeted way to treat the serious
complication of this condition, including heart failure and sudden death.
Fat and Sugar Metabolism During Exercise, With and Without L-carnitine in Patients With Carnitine Transporter Deficiency [Completed]
The investigators wish to investigate fat and sugar metabolism during exercise with and
without L-carnitine supplementation in patients with carnitine transporter deficiency (CTD).
Patients with CTD have low plasma- and muscle concentrations of carnitine, which is believed
to lead to an impaired fat oxidation. Presently there is no cure available for these
patients, but daily intake of L-carnitine has been shown to limit the amount of symptoms.
Little is known about the metabolism during exercise and the pathophysiological mechanisms
causing the symptoms.
Studying the fat and sugar metabolism in CTD patients will contribute to the understanding
of the role of the carnitine transporter in the development of symptoms in these patients.
Furthermore, knowledge about the fat and sugar metabolism in these patients can increase the
understanding of the role of the carnitine transporter in the metabolism healthy persons.
The investigators have included 8 patients with genetically verified CTD in the study and a
group of 10 age- and sex-matched controls. Subjects will perform a 1h cycling test,
exercising at a moderate intensity. By measuring the expiration of carbon dioxide (CO2) and
consumption of oxygen (O2), the investigators can determine the total fatty acid and
carbohydrate oxidation during cycling. At the same time the investigators will measure the
patients' whole body palmitate (fat) and glucose (sugar) oxidation rates using stable
isotope technique.
The patient group will repeat the cycling test after 4 days without taking their usual
L-carnitine treatment. During the treatment break, patients will be admitted to be
continuously monitored for heart rhythm disturbances, which is a known but rarely occurring
complication to untreated CTD.
Since the patients have a defect in their fat metabolism, the investigators expect to find
that they have a reduced ability to burn fat, which is the major source of energy during low
intensity exercise. It is therefore likely, that the CTD patients will benefit from
adjustments in their daily diet, whenever they have to perform physically. By learning about
the metabolism of different dietary substances, fat and sugar, these studies can help to
improve the treatment in terms of dietary recommendations for CTD patients. This will have a
direct impact on the daily life of the patients.
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Page last updated: 2013-02-10
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