Clinical trial NCT02550912: A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
Official title: A Pilot Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 42
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)
timeFrame: At baseline, 12 weeks ,24 weeks
measure: Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)
timeFrame: At baseline, 12 weeks ,24 weeks
Secondary outcomes:
measure: Effect of vitamin D on calcium level
timeFrame: At baseline, 12 weeks ,24 weeks
measure: Effect of vitamin D on phosphorous level
timeFrame: At baseline, 12 weeks ,24 weeks
measure: Effect of vitamin D on alkaline phosphatase level
timeFrame: At baseline,12 weeks ,24 weeks
measure: Effect of vitamin D on parathyroid hormone level
timeFrame: At baseline,12 weeks ,24 weeks
measure: Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)
timeFrame: At baseline, 12 weeks ,24 weeks
measure: Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)
timeFrame: At baseline, 12 weeks ,24 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Pharmacy AinShams University
Study officials:
affiliation: assistant lecturer clinical pharmacy ainshams university
name: sarah f mohamed fahmy, masters
role: PRINCIPAL_INVESTIGATOR
affiliation: professor in clinical pharmacy Ainshams university
name: nagwa A sabri, professor
role: STUDY_DIRECTOR
affiliation: professor in clinical pharmacy Ainshams university
name: manal H elhamamsy, professor
role: STUDY_DIRECTOR
affiliation: professor in pediatrics and genetics ainshams university
name: mohamed A elsawi, professor
role: STUDY_DIRECTOR
affiliation: medical consultant in paediatrics and genetics unit ainshams university
name: osama k zaki, consultant
role: STUDY_DIRECTOR
References: