## Protocol Section
### Identification Module
**NCT ID:** NCT03963479

**Brief Title:** Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

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

#### Organization Study ID Info
**ID:** BSMMU/2018/14607
#### Organization
**Class:** OTHER
**Full Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
### Status Module
#### Completion Date
**Date:** 2019-07-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-07-31

**Type:** ACTUAL

**Last Update Submit Date:** 2019-07-30

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-01-01

**Type:** ACTUAL

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2019-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2019-05-15
**Study First Submit QC Date:** 2019-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

#### Responsible Party

**Investigator Affiliation:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

**Investigator Full Name:** Dr. Farhana Khan

**Investigator Title:** Resident

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Autism Spectrum Disorder

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Combination Product: Magnesium and Vitamin B6

**Label:** Magnesium-Vitamin B6

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**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

**Intervention Names:**

- Combination Product: Magnesium and Vitamin B6

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Magnesium-Vitamin B6

- Placebo

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

**Name:** Magnesium and Vitamin B6

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Autism Spectrum Disorder

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Autism Spectrum Disorder

**Time Frame:** 0 month

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 12 Years

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** farhanakhan488@gmail.com

**Name:** Farhana Khan, MBBS

**Phone:** 8801674255083

**Role:** CONTACT

**Contact 2:**

**Email:** srkhasru@gmail.com

**Name:** Md Sayedur Rahman, MBBS, MPhil

**Phone:** 8801971840757

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Dhaka

**Contacts:**

***Contact 1:***

- **Email:** srkhasru@gmail.com

- **Name:** Md. Sayedur Rahman, MBBS, MPhil

- **Phone:** 8801971840757

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Farhana Khan

**Status:** RECRUITING

**Zip:** 02

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002659

- Term: Child Development Disorders, Pervasive

- ID: D000065886

- Term: Neurodevelopmental Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4623

- Name: Autistic Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M206

- Name: Autism Spectrum Disorder

- Relevance: HIGH

- As Found: Autism Spectrum Disorder

- ID: M5903

- Name: Child Development Disorders, Pervasive

- Relevance: LOW

- As Found: Unknown

- ID: M5902

- Name: Developmental Disabilities

- Relevance: LOW

- As Found: Unknown

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000067877

- Term: Autism Spectrum Disorder

### Intervention Browse Module - Ancestors

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014803

- Term: Vitamin B Complex

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M23026

- Name: Vitamin B 6

- Relevance: HIGH

- As Found: Health Outcomes

- ID: M14583

- Name: Pyridoxal

- Relevance: HIGH

- As Found: Health Outcomes

- ID: M14589

- Name: Pyridoxine

- Relevance: HIGH

- As Found: Health Outcomes

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T474

- Name: Vitamin B6

- Relevance: HIGH

- As Found: Health Outcomes

- ID: T459

- Name: Pyridoxal

- Relevance: HIGH

- As Found: Health Outcomes

- ID: T461

- Name: Pyridoxine

- Relevance: HIGH

- As Found: Health Outcomes

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000025101

- Term: Vitamin B 6

- ID: D000011730

- Term: Pyridoxal

- ID: D000011736

- Term: Pyridoxine

### Misc Info Module

- Version Holder: 2024-05-24
