Clinical Trial for Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X Syndrome (SXF2-8)
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|ClinicalTrials.gov Identifier: NCT02942498|
Recruitment Status : Unknown
Verified September 2016 by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
Recruitment status was: Recruiting
First Posted : October 24, 2016
Last Update Posted : October 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|X Fragile Syndrome||Drug: Vitamin C 10mg/Kg Vitamin E 10 mg/Kg Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Trials Phase III, Double Blind, Crossover to Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X Syndrome|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Vitamin C 10 mg/Kg + Vitamin E 10 mg/Kg
Vitamin C and Vitamin E supplementation 10 mg/kg/ day
Drug: Vitamin C 10mg/Kg Vitamin E 10 mg/Kg
Placebo Comparator: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942498
|Contact: Yolanda De Diego Otero, Ph Dfirstname.lastname@example.org|
|Hospital Regional de Málaga||Recruiting|
|Malaga, Málaga, Spain, 29009|
|Contact: Lucia Pérez Costilla, M.D PhD|