Early Nutritional Intervention in Patients With Autism Spectrum Disorders

NCT01230359 | Completed DMC

• 1 other identifier: 8225/08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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

Keywords

Autism; Children; ASD; Vitamin B6; Magnesium

Outcome Measures

Primary Outcomes (1)

• Measurement of improvement in blood parameters

  Nutritional supplement is provided and the measures of blood tests are done 12 weeks after the participant takes the supplement

  At 12 weeks after getting the nutritional supplement

Secondary Outcomes (1)

• Developmental assessments for ASD

  Baseline and 12 weeks

Study Arms (2)

Vitamin B6 and magnesium

EXPERIMENTAL

Dietary Supplement: Pyridoxine hydrochloride

Tang powder group

PLACEBO COMPARATOR

Other: Tang orange powder

Interventions

Pyridoxine hydrochloride DIETARY_SUPPLEMENT

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

Also known as: Vitamin B6; Super Nu -Thera Registered trade mark kirkman Laboratories

Vitamin B6 and magnesium

Tang orange powder OTHER

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

Tang powder group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Qatar University: collaborator
• Heidelberg University: collaborator

Study Sites (1)

Rumailah Hospital

Doha, Qatar, 3050, Qatar

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Pyridoxine; Vitamin B 6

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 19, 2011

Record last verified: 2011-07

Locations

QA (1)