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 | Completed Phase 3

• 1 other identifier: SXF2-8
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

X Fragile Syndrome

Keywords

behavior, cognitive

Outcome Measures

Primary Outcomes (7)

• Autism Treatment Evaluation Checklist (ATEC).

  32 weeks

• Global Clinical Impression (GCI)

  32 weeks

• Peabody Picture Vocabulary Test (PiVT)

  32 weeks

• Battelle developmental inventory screening

  32 weeks

• Vineland Adaptive Behavior Scales

  32 weeks

• Adverse event reported

  32 weeks

• Quantitative Checklist for Autism in Toddlers (Q-Chat) test

  32 weeks

Secondary Outcomes (4)

• Golberg scale GHQ-28

  32 weeks

• Quality life SF36 test

  32 weeks

• Psychological General Well-Being Index

  32 weeks

• Sleep Disturbance Scale for Children

  32 weeks

Study Arms (2)

Vitamin C 10 mg/Kg + Vitamin E 10 mg/Kg

EXPERIMENTAL

Vitamin C and Vitamin E supplementation 10 mg/kg/ day

Drug: Vitamin C 10mg/Kg Vitamin E 10 mg/Kg

Placebo

PLACEBO COMPARATOR

Placebo solution

Drug: Placebo

Interventions

Vitamin C 10mg/Kg Vitamin E 10 mg/Kg DRUG

Vitamin C 10 mg/Kg + Vitamin E 10 mg/Kg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of Fragile X syndrome by genetic testing of molecular biology, full mutation result methylation.
• Having an older age of 1 year and less than 9 years
• Having signed the informed consent document before starting their participation in the trial.

You may not qualify if:

• Any advanced, severe or unstable disease.
• Individuals with other psychiatric diagnosis as the first diagnosis.
• It have been suffered serious medical problems in the last 12 months.
• Be taking more than 100 mg of vitamin E or C a day in the last month.
• Having physical, mental or sensory impairments that prevent the assessment of effectiveness.
• Hypersensitivity to any component of the preparation.
• Liver failure or severe renal or previous history of kidney stones.
• Any treatment regimen, including treatment with psychotropic drugs and / or anticonvulsant therapy that has not been stable for a period ≥ 4 weeks before randomization.
• Current treatment with more than two psychoactive medications, excluding medication used specifically for the control of seizures.
• Hypoprothrombinemia secondary to vitamin K deficiency
• Sensitivity to any of the compounds of formula treatment.
• Patients diagnosed with congenital or idiopathic methemoglobinemia for diagnosis of glucose-6-phosphate dehydrogenase deficiency.
• Use of oral anticoagulants, iron or vitamin A.
• Forecast initiate or change pharmacological or no pharmacological interventions during the course of the study.
• Patients weighing less than 4.2 kg

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Delos Clinical: collaborator

Study Sites (1)

Hospital Regional de Málaga

Málaga, Málaga, 29009, Spain

Location

Related Publications (3)

• Zandi PP, Anthony JC, Khachaturian AS, Stone SV, Gustafson D, Tschanz JT, Norton MC, Welsh-Bohmer KA, Breitner JC; Cache County Study Group. Reduced risk of Alzheimer disease in users of antioxidant vitamin supplements: the Cache County Study. Arch Neurol. 2004 Jan;61(1):82-8. doi: 10.1001/archneur.61.1.82.

  PMID: 14732624 BACKGROUND

• Castilla P, Davalos A, Teruel JL, Cerrato F, Fernandez-Lucas M, Merino JL, Sanchez-Martin CC, Ortuno J, Lasuncion MA. Comparative effects of dietary supplementation with red grape juice and vitamin E on production of superoxide by circulating neutrophil NADPH oxidase in hemodialysis patients. Am J Clin Nutr. 2008 Apr;87(4):1053-61. doi: 10.1093/ajcn/87.4.1053.

  PMID: 18400731 BACKGROUND

• Barger SW, Goodwin ME, Porter MM, Beggs ML. Glutamate release from activated microglia requires the oxidative burst and lipid peroxidation. J Neurochem. 2007 Jun;101(5):1205-13. doi: 10.1111/j.1471-4159.2007.04487.x. Epub 2007 Mar 30.

  PMID: 17403030 BACKGROUND

MeSH Terms

Conditions

Fragile X Syndrome; Behavior

Interventions

Ascorbic Acid; Vitamin E

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 24, 2016
• Study Start: July 1, 2016
• Primary Completion: September 25, 2017
• Study Completion: October 31, 2018
• Last Updated: July 22, 2022

Record last verified: 2016-09

Locations

ES (1)