A Phase 3 interventional study of Vitamin C 10mg/Kg Vitamin E 10 mg/Kg and Placebo in X Fragile Syndrome, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Completed at 1 site in Spain. Open to participants aged 1 Year to 8 Years. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Phase 3, Interventional, and Treatment
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.
114 studies on the registry are indexed under Fragile X Syndrome; 24 are open to participants now.
This study's enrollment of 34 is below the median of 50 across 91 interventional studies indexed under Fragile X Syndrome.
Browse Fragile X Syndrome studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin C and Vitamin E supplementation 10 mg/kg/ day
Drug: Vitamin C 10mg/Kg Vitamin E 10 mg/Kg
Placebo solution
Drug: Placebo
Drug page: Ascorbic Acid
Placebo
Autism Treatment Evaluation Checklist (ATEC).
Time frame: 32 weeks
Global Clinical Impression (GCI)
Time frame: 32 weeks
Peabody Picture Vocabulary Test (PiVT)
Time frame: 32 weeks
Battelle developmental inventory screening
Time frame: 32 weeks
Vineland Adaptive Behavior Scales
Time frame: 32 weeks
Adverse event reported
Time frame: 32 weeks
Quantitative Checklist for Autism in Toddlers (Q-Chat) test
Time frame: 32 weeks
Golberg scale GHQ-28
Time frame: 32 weeks
Quality life SF36 test
Time frame: 32 weeks
Psychological General Well-Being Index
Time frame: 32 weeks
Sleep Disturbance Scale for Children
Time frame: 32 weeks
The record gives a start of Jul 2016, a primary completion of Sep 2017 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ascorbic Acid
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud