NEWS HIGHLIGHTS
Published Studies Related to 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
Clinical Trials Related to Levocarnitine
Evaluation of Cilostazol in Combination With L-Carnitine [Recruiting]
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.
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.
Valproate and Levocarnitine in Children With Spinal Muscular Atrophy [Not yet recruiting]
Spinal muscular atrophy (SMA), an autosomal recessive disorder, is characterized by muscle
weakness due to degeneration of anterior horn cells in the spinal cord and brain stem
nuclei. It has a variable incidence of 1 in 6700 to 1 in 25000 live births and prevalence of
0. 12 to 25 per 10,000 populations in different geographic areas and genetic constitution. A
homozygous deletion/mutation involving exon 7 in SMN1 (survival motor neuron 1) is present
in around 95% of the cases, resulting in the biochemical deficiency of the SMN protein. A
genomic duplication at the same locus produces nearly identical SMN2 (survival motor neuron
2) that differs from SMN1 by a nucleotide substitution that promotes exon 7 exclusion thus
giving rise to only a fraction of the full length protein. Phenotypic variation in SMA
correlates with the number of SMN2 gene copies and the level of SMN protein in cells.
Several hypotheses including defective inhibition of apoptosis, glutamate excitotoxicity and
lack of a neurotrophic factor(s) in nerve or muscle have been speculated in the pathogenesis
of SMA.
Valproic acid (VPA), a histone deacetylase (HDAC) inhibitor, directly increases SMN
expression in SMA patient-derived cell lines in vitro. Till date 3 open label trials and 1
placebo controlled RCT of VPA in human subjects have been published, all indicating a
possible benefit in strength and/or motor function. Till date there is no effective therapy
for SMA. Therapy is mainly supportive and palliative which can prolong lifespan and prevent
complications to some extent without actually curing the disease.
Children with SMA may have a reduced capacity to synthesis carnitine consequent to
significantly diminished skeletal muscle mass. VPA independently inhibits carnitine
transport and its metabolites deplete carnitine levels by binding to them. So along with
valproate these patients should be supplemented with carnitine.
With this background the investigators have planned a double blind randomized placebo
controlled trial of Valproate and levocarnitine in 60 children (30 each in intervention and
control arm) with Spinal Muscular Atrophy aged 2-15 years over a 2 year period with one
baseline and four follow up visits. The study will be conducted in the Department of
Pediatrics, AIIMS at the Myopathy clinic.
Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy [Recruiting]
Breast cancer is very common and afflicts 1 in 9 North American women. The treatment of
breast cancer often requires the use of chemotherapy including "anthracyclines".
Anthracyclines can damage the heart resulting in heart failure and even death. Clinicians
and researchers are continually seeking methods that will reduce the toxic effects of
anthracycline treatment.
L-carnitine is a substance that is produced naturally in the body and is required for normal
heart function. Animal studies have suggested that L-carnitine protects the heart from the
effects of anthracyclines, however this has not been verified in humans.
This study will assess the potential role of L-carnitine in the prevention of anthracycline
induced heart damage. The investigators will enroll 144 patients into this study. Patients
will be randomly assigned to L-carnitine therapy or to standard care (no L-carnitine
therapy). Patients in the L-carnitine group will receive oral and intravenous L-carnitine
prior to and after their anthracycline therapy. Patients will undergo regular follow up and
testing to assess heart function. The investigators believe that patients treated with
L-carnitine will benefit and have fewer complications associated with anthracycline
treatment.
Early Administration of L-Carnitine in Hemodialysis Patients [Recruiting]
Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an
anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac
dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine
in hemodialysis patients. The patients should be included in the first month after the start
of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be
followed-up during one year.
Reports of Suspected Levocarnitine Side Effects
Toxicity TO Various Agents (4),
Hypophosphataemia (4),
Encephalopathy (3),
Asthenia (3),
Hypocalcaemia (2),
Agitation (1),
Product Substitution Issue (1),
Prothrombin Time Prolonged (1),
Inflammation (1),
Phlebitis (1), more >>
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