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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550912
• Other study ID #: PhD(NO.18)
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2015
• Last updated: July 11, 2016
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism

Intervention

Drug:
• Vitamin D3
vitamin D drops for paediatrics

Other:
• Placebo
glucose syrup with same taste and color to vitamin D3 drops

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy AinShams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)		At baseline, 12 weeks ,24 weeks	No
Primary	Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)		At baseline, 12 weeks ,24 weeks	No
Secondary	Effect of vitamin D on calcium level		At baseline, 12 weeks ,24 weeks	Yes
Secondary	Effect of vitamin D on phosphorous level		At baseline, 12 weeks ,24 weeks	Yes
Secondary	Effect of vitamin D on alkaline phosphatase level		At baseline,12 weeks ,24 weeks	No
Secondary	Effect of vitamin D on parathyroid hormone level		At baseline,12 weeks ,24 weeks	No
Secondary	Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)		At baseline, 12 weeks ,24 weeks	Yes
Secondary	Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)		At baseline, 12 weeks ,24 weeks	Yes