Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 D

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salu

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salu

Dates:
Date Received: October 7, 2016
Date Started: July 2016
Date Completion: December 2017
Last Updated: October 21, 2016
Last Verified: September 2016