Does Clinical Treatment of Mitochondrial Dysfunction Impact Autism Spectrum Disorder (ASD)?
Status:
Unknown status
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
In this study, 50 children between 3 and 12 years old with formally diagnosed autistic
spectrum disorders (ASD) and also having significant mitochondrial dysfunction will be
treated for a 3 month period with the Mitochondrial Cocktail, a combination of specific
nutritional supplements and metabolite intermediates (including anti-oxidants) and bio-energy
substrates. A series of neurological and psychological evaluations will be conducted by
trained evaluators/clinicians to evaluate both the severity and the clinical presentation of
the ASD/mitochondrial dysfunction with each subject at baseline prior to treatment, after the
3 month treatment and again at 6 months, after another 3 month non-treatment period. In
addition, laboratory investigations will be conducted at the same time-points to assess the
mitochondrial dysfunction and cellular biomarkers thought to be associated with autistic and
mitochondrial disorders. These investigations will include the analysis of samples of blood
and cheek/buccal swabs collected from each child to assess select biochemical markers of ASD.
The Mitochondrial Cocktail treatment will be administered at home once a day continuously for
a total of 3 months. All the children in the study will be treated with the same
Mitochondrial Cocktail (an open label study).