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| Name | Class |
|---|---|
| Delos Clinical | OTHER |
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The purpose of this study is to determine vitamin C and vitamin E in combination are effective in the treatment of cognitive and behavior disorder in children with fragile X syndrome.
The combination of vitamin E and vitamin C supplementation has been associated with a lower prevalence (-78%) and incidence (-64%) of Alzheimer's disease in the elderly population. It has recently been shown that dietary vitamin E supplementation reduces the production of free radicals inhibiting NADPH oxidase activity in circulating neutrophils. Another work describes the inhibition of glutamate release by activated microglia in cell cultures incubated with vitamin E, effect that can prevent excitotoxicity.
The investigators propose to evaluate the effectiveness of treatment in neurodevelopmental disorders affected by fragile X syndrome (FXS) with lipophilic compounds antioxidants such as tocopherol and hydrophilic compounds antioxidants such as ascorbic acid, which regulate oxidative stress and improve learning and behavioral mouse model and humans.
Our group has positive results in the use of this combination of antioxidants as a treatment for fragile X syndrome in adolescents. This disease has developed previous clinical trials with EUDRACT codes: 2009-017837-23 and 2013-004276-35.
The use of the combination of vitamin C and E in the treatment of cognitive and behavioral disorder in FXS, is patented PCT-050 187 with reference number 2011070875
This combination will be administered as a single oral dose with a total dose of 10mg / kg / day for each of the vitamins. This dose is maintained within the therapeutic range of both antioxidants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C 10 mg/Kg + Vitamin E 10 mg/Kg | Experimental | Vitamin C and Vitamin E supplementation 10 mg/kg/ day |
|
| Placebo | Placebo Comparator | Placebo solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C 10mg/Kg Vitamin E 10 mg/Kg | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Autism Treatment Evaluation Checklist (ATEC). | 32 weeks | |
| Global Clinical Impression (GCI) | 32 weeks | |
| Peabody Picture Vocabulary Test (PiVT) | 32 weeks | |
| Battelle developmental inventory screening | 32 weeks | |
| Vineland Adaptive Behavior Scales | 32 weeks | |
| Adverse event reported | 32 weeks | |
| Quantitative Checklist for Autism in Toddlers (Q-Chat) test | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Golberg scale GHQ-28 | 32 weeks | |
| Quality life SF36 test | 32 weeks | |
| Psychological General Well-Being Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional de Málaga | Málaga | Málaga | 29009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14732624 | Background | Zandi PP, Anthony JC, Khachaturian AS, Stone SV, Gustafson D, Tschanz JT, Norton MC, Welsh-Bohmer KA, Breitner JC; Cache County Study Group. Reduced risk of Alzheimer disease in users of antioxidant vitamin supplements: the Cache County Study. Arch Neurol. 2004 Jan;61(1):82-8. doi: 10.1001/archneur.61.1.82. | |
| 18400731 | Background |
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| Drug |
Placebo |
|
| 32 weeks |
| Sleep Disturbance Scale for Children | 32 weeks |
| Castilla P, Davalos A, Teruel JL, Cerrato F, Fernandez-Lucas M, Merino JL, Sanchez-Martin CC, Ortuno J, Lasuncion MA. Comparative effects of dietary supplementation with red grape juice and vitamin E on production of superoxide by circulating neutrophil NADPH oxidase in hemodialysis patients. Am J Clin Nutr. 2008 Apr;87(4):1053-61. doi: 10.1093/ajcn/87.4.1053. |
| 17403030 | Background | Barger SW, Goodwin ME, Porter MM, Beggs ML. Glutamate release from activated microglia requires the oxidative burst and lipid peroxidation. J Neurochem. 2007 Jun;101(5):1205-13. doi: 10.1111/j.1471-4159.2007.04487.x. Epub 2007 Mar 30. |
| ID | Term |
|---|---|
| D005600 | Fragile X Syndrome |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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