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 (NCT02942498)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 8 Years

Patient description (medical language): A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination.  The boy is going to a school for students with learning disabilities.  The patient was adopted, and his immunizations are up to date.  Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value      Normal Range     Patient Value
Glucose                    90-120 mg/dl     95 mg/dl
BUN (Blood Urea Nitrogen)  7-24 mg/dl       10 mg/dl
Creatinine                 0.7-1.4 mg/dl    0.8 mg/dl
Calcium                    8.5-10.5 mg/dl   9 mg/dl
Sodium                     134-143 mEq/L    135 mEq/L
Potassium                  3.5-4.5 mEq/L    3.7 mEq/L
Chloride                   95-108 mEq/L     98 mEq/L
CO2                        20-30 mEq/L      25 mEq/L
Blood pH                   7.38-7.42        7. 39

Patient description (patient's own words): My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range.

Does the patient match the trial criteria? Contradiction