Status:

COMPLETED

Early Nutritional Intervention in Patients With Autism Spectrum Disorders

Lead Sponsor:

Hamad Medical Corporation

Collaborating Sponsors:

Qatar University

Heidelberg University

Conditions:

Autism Spectrum Disorders

Stable Clinical Condition in the Last 3 Months

Eligibility:

All Genders

2-10 years

Phase:

NA

Brief Summary

Nutritional supplements like vitamin B6 and magnesium have demonstrated to have beneficial effects in patients with autism spectrum disorders (ASD). The underlying theory for these effects is that spe...

Detailed Description

Autism spectrum disorders (ASDs) are neurodevelopment disorders characterized by impairments in social relatedness and communication, repetitive behaviors, abnormal movement patterns, and sensory dysf...

Eligibility Criteria

Inclusion

  • Children between 2-6 years of age referred to Pediatrics Rehabilitation Clinic with suspected ASD and pre-screened with DSM IV-R.
  • Each patient will be free of psychoactive medication for at least 3 months prior to the entry into the trial.

Exclusion

  • \- Patients with chronic illness or known hormonal or metabolic disease.
  • Patients with known genetic or chromosomal syndromes.
  • Inability of parents to give informed consent, travel to the clinic visits, administer study medication or arrange for completion of rating scales.
  • We will not to exclude children on other concurrent medications (e.g. antibiotics for intercurrent illnesses, etc.) but will record these medications and control their presence in the final analysis. Furthermore, we will not to exclude children with other co- morbid neurological disorders (e.g. seizure disorder may be present in up to 25% of autistic patients). We will record these conditions and use them in the predictor model to understand their relationship with our current management protocol.

Key Trial Info

Start Date :

April 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2011

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01230359

Start Date

April 1 2010

End Date

July 1 2011

Last Update

July 19 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Rumailah Hospital

Doha, Qatar, Qatar, 3050