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Early Nutritional Intervention in Patients With Autism Spectrum Disorders

NCT01230359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-07-19

No results posted yet for this study

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 specific metabolic pathways in neuronal cells, e.g. the methionine cycle, will be more balanced. Most studies have been focused on the clinical outcome with this treatment. The present proposal will examine the effects on the different intermediates of the methionine cycle (methylation and transulfuration capacity), suggested to play an important role for the pathogenesis of ASD. The design is a prospective pilot study, including 40 patients, aged 2-6 yrs, with newly diagnosed ASD. All participants will receive the supplement (vitamin B6, magnesium; Kirkman formula) and placebo in a cross over design. Metabolites in blood and urine will be measured prior to and at the end of the treatments in the different groups. The results will then provide us with information, which will link clinical outcomes with biological markers. Furthermore, the study has also the potential to shed light on the pathogenesis of ASD.

Conditions

  • Autism Spectrum Disorders
  • Stable Clinical Condition in the Last 3 Months

Interventions

DIETARY_SUPPLEMENT

Pyridoxine hydrochloride

2.5 grams per day for subjects weighing upto 27 kilos and 5 g per day for greater than 27 kgs for 12 weeks

OTHER

Tang orange powder

2.5 grams per day for subjects weighing upto 27 kilos and 5 g per day for greater than 27 kgs for 12 weeks

Sponsors & Collaborators

  • Qatar University

    collaborator OTHER

  • Heidelberg University

    collaborator OTHER

  • Hamad Medical Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Qatar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230359 on ClinicalTrials.gov