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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-03-31

Brief Summary

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

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Detailed Description

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

Conditions

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D group

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.

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

vitamin D drops for paediatrics

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

glucose syrup with same taste and color to vitamin D3 drops

Interventions

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Vitamin D3

vitamin D drops for paediatrics

Intervention Type DRUG

Placebo

glucose syrup with same taste and color to vitamin D3 drops

Intervention Type OTHER

Other Intervention Names

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vitamin D drops glucose syrup

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No