Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03963479
• Other study ID #: BSMMU/2018/14607
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2019
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: Farhana Khan, MBBS
• Phone: 8801674255083
• Email: farhanakhan488[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Development Disorders, Pervasive

Intervention

Combination Product:
• Magnesium and Vitamin B6
Magnesium and Vitamin B6 will be given to the enrolled patients for 3 months

Locations

Country	Name	City	State
Bangladesh	Farhana Khan	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autism Spectrum Disorder	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.	3 months
Secondary	Autism Spectrum Disorder	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.	0 month