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

July 11, 2016 updated by: Sarah Farid Mohamed Fahmy, Ain Shams University

A Pilot 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • faculty of pharmacy Ainshams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Vitamin D3
vitamin D drops for paediatrics
Other Names:
  • vitamin D drops
Placebo Comparator: Placebo group
Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group.
Other: Placebo
glucose syrup with same taste and color to vitamin D3 drops
Other Names:
  • glucose syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)
Time Frame: At baseline, 12 weeks ,24 weeks
At baseline, 12 weeks ,24 weeks
Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)
Time Frame: At baseline, 12 weeks ,24 weeks
At baseline, 12 weeks ,24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of vitamin D on calcium level
Time Frame: At baseline, 12 weeks ,24 weeks
At baseline, 12 weeks ,24 weeks
Effect of vitamin D on phosphorous level
Time Frame: At baseline, 12 weeks ,24 weeks
At baseline, 12 weeks ,24 weeks
Effect of vitamin D on alkaline phosphatase level
Time Frame: At baseline,12 weeks ,24 weeks
At baseline,12 weeks ,24 weeks
Effect of vitamin D on parathyroid hormone level
Time Frame: At baseline,12 weeks ,24 weeks
At baseline,12 weeks ,24 weeks
Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)
Time Frame: At baseline, 12 weeks ,24 weeks
At baseline, 12 weeks ,24 weeks
Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)
Time Frame: At baseline, 12 weeks ,24 weeks
At baseline, 12 weeks ,24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: sarah f mohamed fahmy, masters, assistant lecturer clinical pharmacy ainshams university
  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 12, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhD(NO.18)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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