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

Phase 2

Completed

• Conditions: Autism
• Interventions: Other: Placebo; Drug: Vitamin D3

• Registration Number: NCT02550912
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-12
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)	At baseline, 12 weeks ,24 weeks

Trial Locations

Locations (1)

Faculty of Pharmacy AinShams University; 🇪🇬 Cairo, Egypt