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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Collaborator: Delos Clinical
• Treatments: alpha-Tocopherol; Ascorbic Acid; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

1. Diagnosis of Fragile X syndrome by genetic testing of molecular biology, full mutation result methylation.

2. Having an older age of 1 year and less than 9 years

3. Having signed the informed consent document before starting their participation in the trial.

Exclusion Criteria:

1. Any advanced, severe or unstable disease.

2. Individuals with other psychiatric diagnosis as the first diagnosis.

3. It have been suffered serious medical problems in the last 12 months.

4. Be taking more than 100 mg of vitamin E or C a day in the last month.

5. Having physical, mental or sensory impairments that prevent the assessment of effectiveness.

6. Hypersensitivity to any component of the preparation.

7. Liver failure or severe renal or previous history of kidney stones.

8. Any treatment regimen, including treatment with psychotropic drugs and / or anticonvulsant therapy that has not been stable for a period ≥ 4 weeks before randomization.

9. Current treatment with more than two psychoactive medications, excluding medication used specifically for the control of seizures.

10. Hypoprothrombinemia secondary to vitamin K deficiency

11. Sensitivity to any of the compounds of formula treatment.

12. Patients diagnosed with congenital or idiopathic methemoglobinemia for diagnosis of glucose-6-phosphate dehydrogenase deficiency.

13. Use of oral anticoagulants, iron or vitamin A.

14. Forecast initiate or change pharmacological or no pharmacological interventions during the course of the study.

15. Patients weighing less than 4.2 kg