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Completed

NCT Number: NCT02550912

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

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

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Key information

Conditions

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

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Pharmacy AinShams University

Cairo, 02, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Drug

vitamin D drops for paediatrics

Other names: vitamin D drops

Placebo

Other

glucose syrup with same taste and color to vitamin D3 drops

Other names: glucose syrup

Primary outcomes

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

    Time frame: At baseline, 12 weeks ,24 weeks

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

    Time frame: At baseline, 12 weeks ,24 weeks

Secondary outcomes

  1. Effect of vitamin D on calcium level

    Time frame: At baseline, 12 weeks ,24 weeks

  2. Effect of vitamin D on phosphorous level

    Time frame: At baseline, 12 weeks ,24 weeks

  3. Effect of vitamin D on alkaline phosphatase level

    Time frame: At baseline,12 weeks ,24 weeks

  4. Effect of vitamin D on parathyroid hormone level

    Time frame: At baseline,12 weeks ,24 weeks

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

    Time frame: At baseline, 12 weeks ,24 weeks

  6. Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)

    Time frame: At baseline, 12 weeks ,24 weeks

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2015
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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