A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children

NCT02550912 | Completed Phase 2 DMC

• 1 other identifier: PhD(NO.18)
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.

Conditions

Autism

Outcome Measures

Primary Outcomes (2)

• Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)

  At baseline, 12 weeks ,24 weeks

• Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)

  At baseline, 12 weeks ,24 weeks

Secondary Outcomes (6)

• Effect of vitamin D on calcium level

  At baseline, 12 weeks ,24 weeks

• Effect of vitamin D on phosphorous level

  At baseline, 12 weeks ,24 weeks

• Effect of vitamin D on alkaline phosphatase level

  At baseline,12 weeks ,24 weeks

• Effect of vitamin D on parathyroid hormone level

  At baseline,12 weeks ,24 weeks

• Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)

  At baseline, 12 weeks ,24 weeks

Study Arms (2)

Vitamin D group

ACTIVE COMPARATOR

Patients will receive vitamin D drug with generic name: V drops manufactured by Medical Union Pharmaceuticals, Egypt Dosage form: liquid drops Dosage, frequency, and Duration:1000 international units per day for 3 months then 1000 international units per 25 pounds per day for another 3 months.

Drug: Vitamin D3

Placebo group

PLACEBO COMPARATOR

Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group.

Other: Placebo

Interventions

Vitamin D3 DRUG

vitamin D drops for paediatrics

Also known as: vitamin D drops

Vitamin D group

Placebo OTHER

glucose syrup with same taste and color to vitamin D3 drops

Also known as: glucose syrup

Placebo group

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients fulfill fourth edition of Diagnostic and statistical manual of mental Disorders (DSM 4th) criteria for autism

You may not qualify if:

• Patients who had seizures within the past year or History of kidney or liver disease or Taking the following medications or supplements that may affect vitamin D level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. None of the study participants received vitamin D or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Pharmacy AinShams University

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Cholecalciferol; High Fructose Corn Syrup

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dietary Sugars; Dietary Carbohydrates; Carbohydrates; Sugars; Nutritive Sweeteners; Sweetening Agents; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• sarah f mohamed fahmy, masters

  assistant lecturer clinical pharmacy ainshams university

  PRINCIPAL INVESTIGATOR

• nagwa A sabri, professor

  professor in clinical pharmacy Ainshams university

  STUDY DIRECTOR

• manal H elhamamsy, professor

  professor in clinical pharmacy Ainshams university

  STUDY DIRECTOR

• mohamed A elsawi, professor

  professor in pediatrics and genetics ainshams university

  STUDY DIRECTOR

• osama k zaki, consultant

  medical consultant in paediatrics and genetics unit ainshams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in clinical pharmacy

Study Record Dates

• First Submitted: September 12, 2015
• First Posted: September 16, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

EG (1)