Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Unknown; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Combination Product: Magnesium and Vitamin B6

Study type: Interventional

Funder types: Other

Identifiers

NCT03963479

BSMMU/2018/14607

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Magnesium-Vitamin B6

Active Comparator group

Description:

Magnesium (50mg) for ages 1-3 years (100mg) for ages 4-8 years (200mg) for ages 9-12 years Vitamin B6 (25mg) for ages 1-3 years (50mg) for ages 4-8 years (100mg) for ages 9-12years

Treatment:

Combination Product: Magnesium and Vitamin B6

Placebo

Placebo Comparator group

Description:

Magnesium (50mg) for ages 1-3 years (100mg) for ages 4-8 years (200mg) for ages 9-12 years Vitamin B6 (25mg) for ages 1-3 years (50mg) for ages 4-8 years (100mg) for ages 9-12years

Treatment:

Combination Product: Magnesium and Vitamin B6