Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03963479

Enrollment

Registered

2019-05-24

Start date

2019-01-01

Completion date

2019-07-31

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief summary

To determine whether Vitamin B6 and Magnesium improve neurobehavioral status in terms of General observation, Cognitive working, Socialization, Communication and Sensory Dysfunction in patient with Autism Spectrum Disorder.

Interventions

COMBINATION_PRODUCTMagnesium and Vitamin B6

Magnesium and Vitamin B6 will be given to the enrolled patients for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

Inclusion criteria

1. Children between 2 to 12 years of age suspected ASD assessed by DSM-5 and ADCL tool 2. Each patient will be free of psychoactive medication for atleast 3 months prior to the entry into the trial 3. Newly diagnosed patient 4. Co-morbid neurological disorder like hyperactivity

Exclusion criteria

1. Patients with chronic diseases or any known metabolic or hormonal diseases 2. Patients with any known chromosomal or genetic syndromes 3. Patients unable to give informed consent 4. Patients unable to travel to clinical visits or non co-operative

Design outcomes

Primary

Measure	Time frame	Description
Autism Spectrum Disorder	3 months	General observation, Cognitive Working, socialization, Communication, Sensory Dysfunction. At first a autism will be diagnosed by DSM-5 .Then the above mention criterias along with the severity will be diagnosed by Autism Diagnostic Checklist tool by a psychologist.

Secondary

Measure	Time frame	Description
Autism Spectrum Disorder	0 month	The Autism Diagnostic Checklist will be repeated to compare the outcomes in terms of General observation, Cognitive Working, socialization, Communication, Sensory along with the severity of the Autism.

Countries

Bangladesh

Contacts

Primary ContactFarhana Khan, MBBS

farhanakhan488@gmail.com8801674255083

Backup ContactMd Sayedur Rahman, MBBS, MPhil

srkhasru@gmail.com8801971840757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026