Clinical trial: Safety and Efficacy Study of Antioxidants for the Treatment of the Fragile X Syndrome (NCT01329770)

Eligibility criteria:
Inclusion Criteria:

          -  Molecular genetics diagnosis of the syndrome (number of CGG repeats in the FMR1 gene
             over 200).

          -  Presenting characteristic symptoms of fragile X syndrome.

          -  Patients older than 6 years and younger that 19 years.

          -  Signed informed consent by parents and/or legal tutor prior to enrolment in the trial.

          -  Both parents and patients must commit to participate for the duration of the 30 week
             trial.

        Exclusion Criteria:

          -  The study excludes individuals with other neurological disorders not linked to the
             syndrome.

          -  Patients that have had serious medical problems in the previous 12 months.

          -  Are taking more than 100mg of vitamin E or vitamin C daily for the past 4 months.

          -  Have physical problems, mental or sensory impairments that preclude the assessment of
             effectiveness.

          -  Hypersensitivity to any component of the preparation.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 18 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? Entailment